FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 12, 2024Historical recordClass III
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
by GlaxoSmithKline LLC
- Reason
- Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 14, 2024Historical recordClass II
Publix Super Markets, Inc.
- Product
- EGG CUSTARD PIE, NET WT 25 OZ (1 LB 9 OZ) 709 g, packaged in…
- Reason
- Undeclared Tree Nut (Coconut)
- Published
- January 3, 2024
- Distribution
- Domestic distribution only within state…
View recall →
FDA Recall
TerminatedTerminated: July 18, 2024Historical recordClass I
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
by Blistex Inc
- Reason
- Chemical contamination: Presence of benzene
- Published
- December 27, 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.
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