Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh…
Reason Subpotent
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc…
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…
Class II · Moderate risk Ongoing
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E…
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk Ongoing
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only…
Reason Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error…
Class II · Moderate risk Ongoing
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi…
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited…
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited…
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1…
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Terminated
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun…
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219…
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA…
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe…
Reason CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II · Moderate risk Ongoing
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton)…
Reason cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC…
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited…
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka…
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset…
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination