Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIBuprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIBSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIAtropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIApomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIAlbuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIAcetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass II5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIMinoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIMethylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIHydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIChlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIDutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPfizer Inc.Class IVancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Presence of Particulate Matter: Glass particulate matter detected in injectable.
- 2023-02-01FDA-DrugGlaxosmithkline Consumer Healthcare Holdings DBA HaleonClass IAdvil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- 2023-02-01FDA-DrugGlaxosmithkline Consumer Healthcare Holdings DBA HaleonClass IAdvil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- 2023-02-01FDA-DrugGlaxosmithkline Consumer Healthcare Holdings DBA HaleonClass IAdvil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- 2023-02-01FDA-DrugSpectrum Laboratory Products, Inc.Class IEpinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
- 2023-02-01FDA-DrugSpectrum Laboratory Products, Inc.Class IEpinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
- 2023-02-01FDA-DrugNephron Sc IncClass IISterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
CGMP Deviations: potential for trace amounts of product carryover.
- 2023-02-01FDA-DrugNephron Sc IncClass II0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
CGMP Deviations: potential for trace amounts of product carryover.
- 2023-02-01FDA-DrugNephron Sc IncClass IIS2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9
Short Fill
- 2023-02-01FDA-DrugNephron Sc IncClass IIAsthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4
Short Fill
- 2023-02-01FDA-DrugLupin Pharmaceuticals Inc.Class IIIClobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Subpotent Drug: Low assay result observed during long-term stability testing.
- 2023-02-01FDA-DrugPreferred Pharmaceuticals, Inc.Class IIAllopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09.
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
- 2023-02-01FDA-DrugOurPharma LLCClass IIIFentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
Short Fill: Underfilled units.
- 2023-02-01FDA-DrugAscend Laboratories, LLCClass IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.
Failed Dissolution Specification
- 2023-02-01FDA-DrugAscend Laboratories, LLCClass IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.
Failed Dissolution Specification
- 2023-02-01FDA-DrugAscend Laboratories, LLCClass IIMetoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.
Failed Dissolution Specification
- 2023-02-01FDA-DrugAccord Healthcare, Inc.Class IIAllopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
- 2023-01-25FDA-DrugIntersect ENT, Inc.Class IIISINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
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