Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Drug recall information is sourced from the FDA's structured openFDA Enforcement
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Filters
Showing 1,481–1,500 of 17,937 drug recalls
Drug RecallOngoingHistorical recordClass I
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
by Supercore Products Group Inc.
Reason
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Recall initiated
July 12, 2024
Reported by FDA
October 9, 2024
Distribution
Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
Reason
Defective Container: Firm received complaints of broken tube at the seal.
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
by Nivagen Pharmaceuticals Inc
Reason
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
by EnviroServe Chemicals Inc.
Reason
CGMP deviations
Recall initiated
September 18, 2024
Reported by FDA
October 2, 2024
Distribution
Product was sent to one distributor in North Carolina.
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
by Elevate Oral Care
Reason
LABELING: LABEL MIX-UP.
Recall initiated
August 20, 2024
Reported by FDA
September 18, 2024
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
