Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | August 22, 2012 | LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE 400 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML; PROCAINE HCL, P.F. 2% INJECTABLE 300 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1%… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5%… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE)… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F.… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | NADH-FFC 10 MG/CC INJECTABLE 10 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LORAZEPAM 2MG/ML INJECTABLE 10 ML 20 ML 200 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02%… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML; METHYLPREDNISOLONE ACETATE 80MG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PAPAVERINE/ALPROSTADIL 30MG/10MCG/ML INJECTABLE 10 ML; PAPAVERINE/ALPROSTADIL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML)… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FUROSEMIDE*** (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE*** (25X4ML) 10MG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 ML; MEPIVICAINE… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05%… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5%… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG /… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class III | August 22, 2012 | Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd… | Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the… | American Health Packaging | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 ML 700 ML 800 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML;… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE,… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7… | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class II | August 22, 2012 | FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated |
| Class III | August 22, 2012 | Carboplatin Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC… | Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended… | Hospira Inc. | Terminated |
| Class II | August 15, 2012 | Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides… | Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the… | Apotex Corp. | Terminated |
| Class II | August 15, 2012 | OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D… | CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation | Oklahoma Respiratory Care Inc | Terminated |
| Class I | August 15, 2012 | HYDROMORPHONE HYDROCHLORIDE HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled… | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and… | Hospira Inc. | Terminated |
| Class II | August 15, 2012 | Albuterol Sulfate Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials,… | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. | Terminated |
| Class II | August 15, 2012 | Copaxone Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva… | Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class III | August 8, 2012 | Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg.… | Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package… | Axcentria Pharmaceuticals LLC | Terminated |
| Class II | August 8, 2012 | OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL… | Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter. | Cadence Pharmaceuticals | Terminated |
| Class II | August 8, 2012 | Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle,… | Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | August 8, 2012 | Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums,… | Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross… | Bayer HealthCare Pharmaceuticals Inc. | Terminated |
| Class I | August 8, 2012 | Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a)… | A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot… | Eagle Pharmaceuticals Inc. | Terminated |
| Class III | August 8, 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1… | Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities. | Watson Laboratories Inc | Terminated |
| Class II | August 8, 2012 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz… | CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. | Mallinckrodt Inc. | Terminated |
| Class II | August 8, 2012 | Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For… | Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. | Apotex Inc. | Terminated |
| Class III | August 8, 2012 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz… | Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient… | Mallinckrodt Inc. | Terminated |
| Class II | August 8, 2012 | Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr.… | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | August 8, 2012 | Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups,… | Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay… | VistaPharm, Inc. | Terminated |
| Class II | August 8, 2012 | Fosphenytoin sodium Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single… | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability… | West-ward Pharmaceutical Corp. | Terminated |
| Class II | August 8, 2012 | Fosphenytoin sodium Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single… | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability… | West-ward Pharmaceutical Corp. | Terminated |
| Class II | August 8, 2012 | Amlodipine Besylate and Benazepril Hydrochloride Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules,… | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class III | August 1, 2012 | Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr… | Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the… | Stat Rx USA | Terminated |
| Class III | August 1, 2012 | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA… | Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may… | Fougera Pharmaceuticals, Inc. | Terminated |
| Class II | August 1, 2012 | Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S.… | Superpotent; benzocaine | Grandpa Brands Co | Terminated |
| Class II | July 25, 2012 | Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For… | Presence of Particulate Matter | Luitpold Pharmaceuticals, Inc. | Terminated |
| Class III | July 25, 2012 | HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx… | Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room… | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Terminated |
| Class II | July 25, 2012 | Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc.… | Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients… | Meda Pharmaceuticals Inc. | Terminated |
| Class I | July 25, 2012 | Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit… | Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL | Hospira Inc. | Terminated |
| Class III | July 25, 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct.… | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip… | Bayer Healthcare, LLC | Terminated |
| Class III | July 25, 2012 | Ciprofloxacin Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in… | Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due… | Pack Pharmaceuticals | Terminated |
| Class III | July 25, 2012 | Pitocin Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured… | Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)".… | JHP Pharmaceuticals, LLC | Terminated |
| Class III | July 25, 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC,… | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip… | Bayer Healthcare, LLC | Terminated |
| Class II | July 18, 2012 | Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl… | Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium,… | Kimberly-Clark Corporation | Terminated |
| Class III | July 18, 2012 | HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for:… | Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time… | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Terminated |
| Class II | July 18, 2012 | Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) ,… | Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium,… | Kimberly-Clark Corporation | Terminated |
| Class II | July 18, 2012 | Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL… | Impurities/Degradation Products: exceeded specification at 3 month stability testing | VistaPharm, Inc. | Terminated |
| Class II | July 18, 2012 | Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets,… | Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700… | GlaxoSmithKline Inc | Terminated |
| Class II | July 18, 2012 | Daytrana Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2… | Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the… | Noven Pharmaceuticals, Inc. | Terminated |
| Class III | July 18, 2012 | NEXIUM Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx… | Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules… | ASTRA ZENECA Lp | Terminated |
| Class II | July 11, 2012 | Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india… | Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight) | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class III | July 11, 2012 | Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz… | Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. | Ranbaxy Inc. | Terminated |
| Class III | July 11, 2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson… | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc | Terminated |
| Class II | July 11, 2012 | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi… | CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently… | sanofi-aventis US, Inc. | Terminated |
| Class III | July 11, 2012 | Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100… | Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly… | Health Plus Incorporated | Terminated |
| Class II | July 11, 2012 | Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi… | CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently… | sanofi-aventis US, Inc. | Terminated |
| Class III | July 11, 2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only,… | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc | Terminated |
| Class III | July 11, 2012 | Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count… | Defective Container; damaged blister units | Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. | Terminated |
| Class III | July 11, 2012 | Loxapine Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson… | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc | Terminated |
| Class III | July 11, 2012 | Loxapine Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson… | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc | Terminated |
| Class III | July 11, 2012 | Loxapine Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson… | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc | Terminated |
| Class II | July 4, 2012 | Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is… | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Lloyd Inc | Terminated |
| Class II | July 4, 2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for:… | Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point | Shionogi Inc. | Terminated |
| Class II | July 4, 2012 | Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by:… | Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C… | Physicians Total Care, Inc. | Terminated |
| Class II | July 4, 2012 | Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is… | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Lloyd Inc | Terminated |
| Class II | July 4, 2012 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX,… | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Lloyd Inc | Terminated |
| Class II | July 4, 2012 | Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC… | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Lloyd Inc | Terminated |
| Class II | July 4, 2012 | Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and… | Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | July 4, 2012 | Mefloquine Hydrochloride Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton,… | Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | June 27, 2012 | LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde | CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which… | Linde Gas LLC | Terminated |
| Class II | June 27, 2012 | Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS… | Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm… | Kutol Products Co Inc | Terminated |
| Class II | June 27, 2012 | Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed:… | Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. | Physicians Total Care, Inc. | Terminated |
| Class I | June 27, 2012 | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician… | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Physicians Total Care, Inc | Terminated |
| Class I | June 27, 2012 | Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician… | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Physicians Total Care, Inc | Terminated |
| Class III | June 27, 2012 | MAGNESIUM SULFATE IN WATER Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL… | Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. | Hospira, Inc. | Terminated |
| Class III | June 27, 2012 | Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser… | Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages… | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class II | June 27, 2012 | Zemplar Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx… | CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign… | Abbott Laboratories | Terminated |
| Class II | June 20, 2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3… | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… | Noven Pharmaceuticals, Inc. | Terminated |
| Class III | June 20, 2012 | DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By:… | Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not… | Quadrant Chemical Corporation | Terminated |
| Class II | June 20, 2012 | Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC,… | Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic… | Bausch & Lomb, Inc. | Terminated |
| Class III | June 20, 2012 | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per… | Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in… | Endo Pharmaceuticals, Inc. | Terminated |
| Class II | June 20, 2012 | Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use… | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released… | Ben Venue Laboratories Inc | Terminated |
| Class II | June 20, 2012 | Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b)… | Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide. | Airgas Inc | Terminated |
| Class II | June 20, 2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6… | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | June 20, 2012 | CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC… | Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. | Luitpold Pharmaceuticals, Inc. | Terminated |
| Class II | June 20, 2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1… | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | June 20, 2012 | Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in… | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released… | Ben Venue Laboratories Inc | Terminated |
| Class II | June 20, 2012 | Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count… | Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product… | Physicians Total Care, Inc. | Terminated |
| Class II | June 20, 2012 | diazepam Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL… | Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of… | Meridian Medical Technologies a Pfizer Company | Terminated |
| Class II | June 20, 2012 | Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2… | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | June 20, 2012 | propofol Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL… | Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as… | Hospira, Inc. | Terminated |