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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
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II November 4, 2015 TESTOSTERONE, Pellet, 70 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD &… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ESTRADIOL, Injectable Solution, 20 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size:… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 112 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 HYDROXOCOBALAMIN (COMPOUNDED), Injectable Solution, 1 mg/mL, 30 mL syringe, Rx only, JD &… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 PROCAINE MDV, Injectable Solution,1%, container sizes: 30mL and 300mL, Rx only, JD & SN… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 30 mL… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 116 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ESTRADIOL, Pellet, 12.5 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 90 mg, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S.… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL syringe , Rx only, JD & SN Inc, DBA… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution, 15 MG/ML, syringe size:… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 125 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ETHYL ALCOHOL (STERILE FOR INJECTION) 100%, Injectable Solution, 200 PROOF, 30 mL… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 76 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 METHYLCOBALAMIN, injectable Solution, 10 MG/ML, syringe sizes: 10mL; 22.5mL; and 30mL, Rx… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 60 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 METHYLCOBALAMIN/HYDROXOCOBALAMIN PRESERVATIVE FREE UNIT DOSE SYRINGES, Injectable… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 106 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 FOLIC ACID (COMPOUNDED), Injectable Solution, 5 mg/mL, 5 mL syringe, Rx only, JD & SN… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 80 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 110 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 1000 units/1 mL per syringe,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ESTRADIOL, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ALPROSTADIL/PROCAINE, Injectable Solution, 20 MCG/0.1%/ML, 10 mL vial, Rx only, JD & SN… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 4.5/5.4/5.4MG/9ML, 9mL syringe, Rx only,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 PYRIDOXINE HCL, injectable Solution, 100 mg/mL, 30mL syringe, Rx only, JD & SN Inc, DBA… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 250 UNITS/0.25ML per syringe, Rx… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CHORIONIC GONADOTROPIN, Injectable Solution, 4000 UNITS/ mL, 8 mL vial, Rx only, JD & SN… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial, Rx only, JD &… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 5mL… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 115 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 ALPROSTADIL, Injectable Solution, 40 MCG/ML, 10 mL vials, Rx only, JD & SN Inc, DBA Moses… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TRIMIX, injectable Solution, 40MG/2MG/40MCG/ML, syringe size: 10mL, Rx only, JD & SN Inc,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 150 UNITS/0.150 ML per syringe,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx only, JD &… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE, Injectable Solution, 1.5/1.5 mg/0.25 mL… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 DEXPANTHENOL, Injectable Solution, 250 MG/ML, 30 mL syringes, Rx only, JD & SN Inc, DBA… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 TESTOSTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake… Lack of Assurance of Sterility: all sterile compounded products within expiry Chen Shwezin, Inc. dba Park Compounding Pharmacy Terminated
Class II November 4, 2015 HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 1.5 mg/0.25… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 mL syringe, Rx only, JD &… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 METHYLCOBALAMIN MDV, Injectable Solution, 5 MG/ML, 30 mL syringe, Rx only, JD & SN Inc,… Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy Terminated
Class II November 4, 2015 Xanax Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia… Subpotent Drug Pfizer Inc. Terminated
Class III October 28, 2015 Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass… Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate… Hospira Inc. Ongoing
Class III October 28, 2015 Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)… Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on… Rx PAK Terminated
Class II October 21, 2015 P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric… Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that… Tribute Pharmaceuticals US Inc. Terminated
Class II October 21, 2015 P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 ALLERGY RELIEF Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular… Subpotent Drug Ferring Pharmaceuticals Inc Terminated
Class III October 21, 2015 Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid)… Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that… Tribute Pharmaceuticals US Inc. Terminated
Class III October 21, 2015 Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count… Cross Contamination With Other Products: Potential cross-contamination of cephalosporin. Midway Importing, Inc Terminated
Class III October 21, 2015 Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b)… Lack of Assurance of Sterility: Failed preservative effectiveness testing Apotex Inc. Terminated
Class III October 21, 2015 Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4… Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover… The Mentholatum Co. Terminated
Class III October 21, 2015 HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a)… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209… Lack of assurance of sterility Bedford Pharmacy Terminated
Class II October 21, 2015 P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class II October 21, 2015 Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class II October 21, 2015 P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110,… Lack of assurance of sterility Bedford Pharmacy Terminated
Class III October 21, 2015 Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class III October 21, 2015 CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Terminated
Class II October 21, 2015 Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only,… Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. Actavis Laboratories, FL, Inc. Terminated
Class II October 21, 2015 Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in… Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process Nephron Pharmaceuticals Corp. Terminated
Class III October 21, 2015 Furosemide FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane… CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was… Boehringer Ingelheim Roxane Inc Terminated
Class III October 21, 2015 Furosemide FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane… CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was… Boehringer Ingelheim Roxane Inc Terminated
Class II October 14, 2015 Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg… Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets. Merck Sharp & Dohme, Wilson Facility Terminated
Class II October 14, 2015 Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection,… Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area… Diabetes Corporation of America dba DCA Pharmacy Terminated
Class II October 14, 2015 Daytrana Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30… Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. Noven Pharmaceuticals, Inc. Terminated
Class III October 7, 2015 METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by… Defective Container: Lids on unit dose cups are not fully qualified. VistaPharm, Inc. Terminated
Class I October 7, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial,… Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility… Hartley Medical Center Pharmacy, Incorporated Terminated
Class III October 7, 2015 Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx… Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits. Apotex Inc. Terminated
Class I October 7, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl… Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility… Hartley Medical Center Pharmacy, Incorporated Terminated
Class II October 7, 2015 LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50… Subpotent Drug: trace amounts of methylcobalamin in compounded drug. Eagle Pharmacy, Inc. Terminated
Class III October 7, 2015 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne… Subpotent Drug: Salicylic acid is subpotent. Guthy-Renker LLC Terminated
Class III October 7, 2015 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne… Subpotent Drug: Salicylic acid is subpotent. Guthy-Renker LLC Terminated
Class III October 7, 2015 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne… Subpotent Drug: Salicylic acid is subpotent. Guthy-Renker LLC Terminated
Class II October 7, 2015 All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL… Lack of Assurance of Sterility Medistat RX L.L.C. Terminated
Class III October 7, 2015 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne… Subpotent Drug: Salicylic acid is subpotent. Guthy-Renker LLC Terminated
Class III October 7, 2015 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne… Subpotent Drug: Salicylic acid is subpotent. Guthy-Renker LLC Terminated
Class I September 30, 2015 Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class I September 30, 2015 PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class I September 30, 2015 PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class I September 30, 2015 Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class I September 30, 2015 PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class I September 30, 2015 Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class II September 30, 2015 FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc.,… Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment… Allergan Sales, LLC Terminated
Class II September 30, 2015 BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10… Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment… Allergan Sales, LLC Terminated
Class I September 30, 2015 PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class I September 30, 2015 PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which… Pharmedium Services, LLC Terminated
Class II September 30, 2015 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose… Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch. Baxter Healthcare Corporation Terminated
Class II September 30, 2015 Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment,… Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment… Allergan Sales, LLC Terminated
Class II September 30, 2015 Lidocaine Hydrochloride 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx… Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass… Hospira, Inc. Ongoing
Class II September 30, 2015 Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net… Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment… Allergan Sales, LLC Terminated
Class II September 23, 2015 Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile -… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix MEDIUM (15/0.5/5) (MFG) Injectable, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 65 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 42 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 DAY KIT, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Quad-Mix 1 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile -… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Vitatrim Active Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile -… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated