FDA Recall
Terminated
Historical recordClass II
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification test results.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
by Apotex Corp.
- Reason
- CGMP Deviations: potential presence of Burkholderia cepacia complex
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Meta Psyllium Fiber Capsules packaged as 100 count or 160 co…
- Reason
- Illegible Label
- Published
- February 28, 2024
- Distribution
- Alabama, Arizona, Arkansas, California,…
View recall →
FDA Recall
Terminated
Historical recordClass II
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
by Teva Pharmaceuticals USA, Inc
- Reason
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
by Teva Pharmaceuticals USA, Inc
- Reason
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
UNFI General Corporate
- Product
- Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Gol…
- Reason
- The ingredient Triticale is not identified as wheat.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
by Amerisource Health Services LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
by NATCO Pharma Limited
- Reason
- CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
by MEDLINE INDUSTRIES, LP - Northfield
- Reason
- Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
by Amerisource Health Services LLC
- Reason
- CGMP Deviations
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Misprint on tablet
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Misprint on tablet
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
by Kilitch Healthcare India Limited
- Reason
- Non-Sterility
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
by Kilitch Healthcare India Limited
- Reason
- Non-Sterility
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid
by Kilitch Healthcare India Limited
- Reason
- Non-Sterility
- Published
- February 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
by Kilitch Healthcare India Limited
- Reason
- Non-Sterility
- Published
- February 14, 2024
- 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.
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