Drug and pharmaceutical recalls
17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-08-02FDA-DrugSCA PharmaceuticalsClass IIFentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
cGMP deviations: due to shipment of rejected units.
- 2023-08-02FDA-DrugNew Vitalis Pharmacy LLC dba New Vitalis PharmacyClass IITestosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
Lack of Assurance of Sterility
- 2023-08-02FDA-DrugKramer Laboratories, Inc.Class IISafe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- 2023-08-02FDA-DrugKramer Laboratories, Inc.Class IISafe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- 2023-08-02FDA-DrugALEMBIC PHARMACEUTICALS, INC.Class IIDiclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
Defective Delivery System
- 2023-08-02FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIMethylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Presence of Foreign Substance: Metal embedded in a tablet.
- 2023-08-02FDA-DrugSagent PharmaceuticalsClass IIOxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Lack of Assurance of Sterility
- 2023-08-02FDA-DrugSagent PharmaceuticalsClass IIOxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Lack of Assurance of Sterility
- 2023-08-02FDA-DrugSagent PharmaceuticalsClass IIOxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Lack of Assurance of Sterility
- 2023-07-26FDA-DrugGlenmark Therapeutics, Inc.Class IIFamotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
- 2023-07-26FDA-DrugSterRx, LLCClass IINorepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
Lack of Assurance of Sterility
- 2023-07-26FDA-DrugSterRx, LLCClass IINorepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
Lack of Assurance of Sterility
- 2023-07-26FDA-DrugSterRx, LLCClass IINorepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
Lack of Assurance of Sterility
- 2023-07-26FDA-DrugSterRx, LLCClass IINorepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
Lack of Assurance of Sterility
- 2023-07-26FDA-DrugSterRx, LLCClass IISodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Lack of Assurance of Sterility
- 2023-07-26FDA-DrugNew England Life Care, Inc. dba Advanced Compounding SolutionsClass IIVancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- 2023-07-26FDA-DrugNew England Life Care, Inc. dba Advanced Compounding SolutionsClass IIROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- 2023-07-26FDA-DrugNew England Life Care, Inc. dba Advanced Compounding SolutionsClass IIPHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- 2023-07-26FDA-DrugNew England Life Care, Inc. dba Advanced Compounding SolutionsClass IISUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- 2023-07-26FDA-DrugAscend Laboratories, LLCClass IIFingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
Failed Dissolution Specifications
- 2023-07-26FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIILoteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
- 2023-07-26FDA-DrugDr Reddy's Laboratories LimitedClass IITizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
- 2023-07-19FDA-DrugCipla USA, Inc.Class IAlbuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- 2023-07-19FDA-DrugGlobal Pharma Healthcare Private LimitedClass IIDelsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
- 2023-07-19FDA-DrugGlobal Pharma Healthcare Private LimitedClass IDelsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- 2023-07-19FDA-DrugGlobal Pharma Healthcare Private LimitedClass IIArtificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
- 2023-07-19FDA-DrugGlobal Pharma Healthcare Private LimitedClass IArtificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- 2023-07-19FDA-DrugAccord Healthcare, Inc.Class IIBivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
Presence of Particulate Matter: Particulate matter identified as fiber.
- 2023-07-19FDA-DrugAccord Healthcare, Inc.Class IIAtropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.
Presence of Particulate Matter: Particulate matter identified as fiber.
- 2023-07-19FDA-DrugB. Braun Medical Inc.Class II0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Lack of assurance of sterility: bags have the potential to leak.
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