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 | February 5, 2020 | Testosterone Topical Cream 4% | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy | Terminated |
| Class II | February 5, 2020 | Liothyronine (T3) 92.5 MCG | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy | Terminated |
| Class III | February 5, 2020 | Montelukast Sodium Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for :… | Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product | Macleods Pharma Usa Inc | Terminated |
| Class II | January 29, 2020 | Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count… | CGMP Deviations: Presence of NDMA impurity detected in product. | Denton Pharma, Inc. | Terminated |
| Class II | January 29, 2020 | Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#:… | Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs) | Tuscano and Delucia Group (DBA Entropic Labs) | Terminated |
| Class II | January 29, 2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | January 29, 2020 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC… | CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established… | RemedyRepack Inc. | Terminated |
| Class II | January 29, 2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | January 29, 2020 | Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count… | CGMP Deviations: Presence of NDMA impurity detected in product. | Denton Pharma, Inc. | Terminated |
| Class II | January 29, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles… | CGMP Deviations: Presence of NDMA impurity detected in product. | Preferred Pharmaceuticals, Inc | Terminated |
| Class II | January 29, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC:… | CGMP Deviations: Presence of NDMA impurity detected in product. | Preferred Pharmaceuticals, Inc | Terminated |
| Class II | January 29, 2020 | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60… | CGMP Deviations: Presence of NDMA impurity detected in product. | H J Harkins Company Inc dba Pharma Pac | Terminated |
| Class III | January 29, 2020 | Methylprednisolone Sodium Succinate methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by:… | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with… | Hikma Pharmaceuticals USA Inc. | Terminated |
| Class II | January 29, 2020 | NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For… | Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2). | Advanced Accelerator Applications USA, Inc. | Terminated |
| Class II | January 22, 2020 | sumatriptan succinate Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card… | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class I | January 22, 2020 | Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray… | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp | Terminated |
| Class II | January 22, 2020 | Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg… | Subpotent | Letco Medical LLC | Terminated |
| Class II | January 22, 2020 | TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count… | cGMP violations | Wisconsin Pharmacal Company, LLC | Terminated |
| Class III | January 22, 2020 | Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg;… | CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | January 22, 2020 | BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class I | January 22, 2020 | Panther Platinum 30000 Capsules, in green, black background with white, red text in… | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp | Terminated |
| Class II | January 22, 2020 | BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class I | January 22, 2020 | Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in… | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp | Terminated |
| Class II | January 22, 2020 | BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class I | January 22, 2020 | Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver… | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp | Terminated |
| Class II | January 22, 2020 | TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713)… | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card,… | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | January 22, 2020 | Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only,… | Failed Impurities/Degradation Specifications: High out of specification results for related compounds. | AVKARE Inc. | Terminated |
| Class II | January 22, 2020 | BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion | Terminated |
| Class II | January 22, 2020 | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL)… | Presence of Particulate Matter: filmy/cloudy particulate observed in vial. | McGuff Compounding Pharmacy Services, Inc. | Terminated |
| Class II | January 22, 2020 | Ketorolac Tromethamine Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose… | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. | Terminated |
| Class I | January 22, 2020 | Ketorolac Tromethamine Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC… | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. | Terminated |
| Class III | January 22, 2020 | Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396… | Microbial contamination of non-sterile product. | Sigan Industries Inc. | Terminated |
| Class III | January 22, 2020 | MOXIFLOXACIN Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical… | Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. | AuroMedics Pharma LLC | Terminated |
| Class II | January 22, 2020 | Testosterone Cypionate Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple… | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS… | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | January 22, 2020 | Testosterone Cypionate Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial… | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS… | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | January 15, 2020 | Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous… | Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | January 15, 2020 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark… | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 15, 2020 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AAA Pharmaceutical, Inc. | Terminated |
| Class II | January 15, 2020 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark… | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 15, 2020 | Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance… | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Terminated |
| Class II | January 15, 2020 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark… | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 15, 2020 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark… | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 15, 2020 | Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AAA Pharmaceutical, Inc. | Terminated |
| Class II | January 15, 2020 | Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count… | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Appco Pharma LLC | Terminated |
| Class II | January 15, 2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC,… | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Appco Pharma LLC | Terminated |
| Class II | January 15, 2020 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark… | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 15, 2020 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark… | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 15, 2020 | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance… | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Terminated |
| Class II | January 15, 2020 | Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance… | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Terminated |
| Class III | January 15, 2020 | SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6… | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs | Terminated |
| Class III | January 15, 2020 | SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt… | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs | Terminated |
| Class III | January 15, 2020 | SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz… | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs | Terminated |
| Class III | January 15, 2020 | SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz… | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs | Terminated |
| Class I | January 8, 2020 | Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male… | Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. | Natures Rx | Terminated |
| Class III | January 8, 2020 | Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5… | Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity. | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | January 8, 2020 | PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external… | Superpotent Drug: Salicylic acid content is above the firm's specification. | Island Kinetics, Inc. d.b.a. CoValence Laboratories | Terminated |
| Class II | January 8, 2020 | MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10… | Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained… | Akorn, Inc. | Terminated |
| Class II | January 8, 2020 | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only,… | CGMP Deviations: Presence of NDMA impurity detected in product. | American Health Packaging | Terminated |
| Class II | January 8, 2020 | Ranitidine RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Granules India Limited | Ongoing |
| Class III | January 1, 2020 | NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL)… | Subpotent Drug | Pharmedium Services, LLC | Terminated |
| Class III | January 1, 2020 | NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL)… | Subpotent Drug | Pharmedium Services, LLC | Terminated |
| Class III | January 1, 2020 | NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL)… | Subpotent Drug | Pharmedium Services, LLC | Terminated |
| Class II | January 1, 2020 | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS… | Subpotent Drug: Supplier indicated assay results did not meet specifications. | Spectrum Laboratory Products | Terminated |
| Class I | December 25, 2019 | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed… | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial… | Lannett Company, Inc. | Terminated |
| Class II | December 25, 2019 | Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by… | Failed Impurities/Degradation Specifications | Medisca, Inc. | Terminated |
| Class II | December 25, 2019 | Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc.… | Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles.. | AuroMedics Pharma LLC | Terminated |
| Class III | December 25, 2019 | VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g).… | Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister… | Apothecus Pharmaceutical Corp. | Terminated |
| Class III | December 25, 2019 | memantine hydrochloride Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles… | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | December 18, 2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by:… | Presence of Foreign Substance: Presence of a foreign object in a single tablet. | Jubilant Cadista Pharmaceuticals, Inc. | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by… | Lack of sterility assurance. | Surgery Pharmacy Services Inc | Terminated |
| Class II | December 18, 2019 | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60… | CGMP Deviations: Presence of NDMA impurity detected in product. | Preferred Pharmaceuticals, Inc | Terminated |
| Class II | December 18, 2019 | Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884),… | Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes. | OraLabs, Incorporated | Terminated |
| Class II | December 18, 2019 | Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific… | Lack of sterility assurance. | Surgery Pharmacy Services Inc | Terminated |
| Class II | December 18, 2019 | Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT… | Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). | SCA Pharmaceuticals, LLC | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging,… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth… | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces… | Coast Quality Pharmacy, LLC dba Anazao Health | Terminated |
| Class II | December 18, 2019 | Vancomycin Hydrochloride Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials… | Discoloration: Product complaints of discoloration after reconstitution of vials. | AuroMedics Pharma LLC | Terminated |
| Class I | December 18, 2019 | Mirtazapine Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo… | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain… | AuroMedics Pharma LLC | Terminated |
| Class II | December 18, 2019 | Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count… | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. | Ongoing |
| Class III | December 18, 2019 | clobetasol propionate Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27)… | Defective delivery system; product is not foaming or is coming out as liquid. | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class I | December 18, 2019 | Mirtazapine Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo… | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain… | AuroMedics Pharma LLC | Terminated |
| Class II | December 18, 2019 | Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. | Ongoing |
| Class III | December 18, 2019 | clobetasol propionate Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC… | Defective delivery system; product is not foaming or is coming out as liquid. | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class II | December 18, 2019 | Ranitidine Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. | Ongoing |
| Class II | December 18, 2019 | Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count… | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. | Ongoing |
| Class II | December 18, 2019 | Ranitidine Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. | Ongoing |
| Class II | December 18, 2019 | Dextrose 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira,… | Labeling: Incorrect or Missing Lot and/or expiration date. | Pfizer Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9%… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC | Ongoing |
| Class II | December 11, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC | Ongoing |
| Class II | December 11, 2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for… | Microbial contamination of non-sterile product. | Fagron, Inc | Terminated |
| Class II | December 11, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9%… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga,… | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC | Ongoing |
| Class II | December 11, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC | Ongoing |
| Class II | December 11, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9%… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9%… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL)… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |
| Class II | December 11, 2019 | fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One… | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. | Terminated |