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.
- 2024-06-05FDA-DrugLupin Pharmaceuticals Inc.Class IICefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
Defective container: lack of seal integrity.
- 2024-06-05FDA-DrugRubicon Research Private LimitedClass IIMetoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Presence of Foreign Substance: metal in tablet
- 2024-06-05FDA-DrugImprimis NJOF, LLCClass IIMoxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Lack of Assurance of Sterility
- 2024-06-05FDA-DrugImprimis NJOF, LLCClass IIMoxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Lack of Assurance of Sterility
- 2024-06-05FDA-DrugImprimis NJOF, LLCClass IIDexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
Lack of Assurance of Sterility
- 2024-06-05FDA-DrugImprimis NJOF, LLCClass IIDexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
Lack of Assurance of Sterility
- 2024-06-05FDA-DrugImprimis NJOF, LLCClass IIEpinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Lack of Assurance of Sterility
- 2024-06-05FDA-DrugRevive Rx LLC dba Revive Rx PharmacyClass ITirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
- 2024-06-05FDA-DrugDr. Reddy's Laboratories, Inc.Class IIZoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Lack of Assurance of Sterility: Leaking vials
- 2024-06-05FDA-DrugGenentech, Inc.Class IICathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- 2024-05-29FDA-DrugHikma Injectables USA IncClass IPhenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
- 2024-05-29FDA-DrugAmerican Regent, Inc.Class IIVasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
Subpotent product in addition to having out-of-specification results for impurities.
- 2024-05-29FDA-DrugSOMERSET THERAPEUTICS LLCClass IIHaloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- 2024-05-29FDA-DrugPreferred Pharmaceuticals, Inc.Class IIDuloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2024-05-29FDA-DrugDr. Reddy's Laboratories, Inc.Class IIISirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Failed Impurities/Degradation Specifications
- 2024-05-29FDA-DrugAmerican Regent, Inc.Class IIniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Lack of Assurance of Sterility.
- 2024-05-29FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIIXelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Failed Release Testing: Out of specification for particulate matter test.
- 2024-05-22FDA-DrugPharma Nobis LLCClass IIMeijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
- 2024-05-22FDA-DrugPharma Nobis LLCClass IICVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
- 2024-05-22FDA-DrugSagent PharmaceuticalsClass IIMethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Presence of Particulate Matter: Potential for black particulates in the drug product.
- 2024-05-22FDA-DrugMACLEODS PHARMA USA, INCClass IILosartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
Presence of foreign substance: plastic-like substance.
- 2024-05-22FDA-DrugLupin Pharmaceuticals Inc.Class IICefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- 2024-05-22FDA-DrugLupin Pharmaceuticals Inc.Class IICefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- 2024-05-22FDA-DrugDercher Enterprises, Inc., DBA Gordon LaboratoriesClass IIGordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
cGMP Deviations
- 2024-05-22FDA-DrugStop Clopez CorpClass ISchwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Marketed Without An Approved NDA/ANDA
- 2024-05-15FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIAmphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
Out of specification for assay
- 2024-05-15FDA-DrugAurobindo Pharma USA Inc.Class IIClorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Discoloration: Dotted and yellow spots on tablets
- 2024-05-15FDA-DrugAurobindo Pharma USA Inc.Class IIClorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Discoloration: Dotted and yellow spots on tablets
- 2024-05-15FDA-DrugAcella Pharmaceuticals, LLCClass IIISodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Subpotent drug
- 2024-05-15FDA-DrugRemedyRepack Inc.Class IITraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
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