FDA Recall
Terminated
Historical recordClass II
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin 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.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin 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
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: Glass particulate matter detected in injectable.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Advil 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
by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
- Reason
- Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Advil 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
by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
- Reason
- Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Advil (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
by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
- Reason
- Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Epinephrine (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.
by Spectrum Laboratory Products, Inc.
- Reason
- Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile 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.
by Nephron Sc Inc
- Reason
- CGMP Deviations: potential for trace amounts of product carryover.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% 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.
by Nephron Sc Inc
- Reason
- CGMP Deviations: potential for trace amounts of product carryover.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S2 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
by Nephron Sc Inc
- Reason
- Short Fill
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Asthmanefrin 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
by Nephron Sc Inc
- Reason
- Short Fill
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clobetasol 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
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug: Low assay result observed during long-term stability testing.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoprolol 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.
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specification
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
by Pharmacy Innovations
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.