April 23, 2025DrugsFDA
Direct Rx recalls CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC
Hazard: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
April 23, 2025DrugsFDA
Eugia US LLC recalls Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC,
Hazard: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
April 23, 2025DrugsFDA
Chattem Inc recalls Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Bo
Hazard: CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
April 16, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd.,
Hazard: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
April 16, 2025DrugsFDA
Alchemee, LLC recalls Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b)
Hazard: Chemical contamination: Presence of benzene
April 16, 2025DrugsFDA
Alchemee, LLC recalls Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, C
Hazard: Chemical contamination: Presence of benzene
April 16, 2025DrugsFDA
Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC,
Hazard: Lack of Assurance of Sterility: Media fill with bacterial contamination
April 16, 2025DrugsFDA
Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,
Hazard: Lack of Assurance of Sterility: Media fill with bacterial contamination
April 16, 2025DrugsFDA
Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,
Hazard: Lack of Assurance of Sterility: Media fill with bacterial contamination
April 16, 2025DrugsFDA
Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So
Hazard: Lack of Assurance of Sterility: Media fill with bacterial contamination
April 16, 2025DrugsFDA
Somerset Therapeutics Private Limited recalls Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Ther
Hazard: Lack of Assurance of Sterility: Media fill with bacterial contamination
April 16, 2025DrugsFDA
B. Braun Medical Inc recalls 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Bra
Hazard: Presence of Particulate Matter
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Mem
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceutica
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx On
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Dis
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pack
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pith
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufac
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pi
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Phar
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx o
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limite
Hazard: CGMP Deviations