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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Filters
Showing 1,521–1,540 of 17,937 drug recalls
Drug RecallTerminatedHistorical recordClass I
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
by A-S Medication Solutions LLC
Reason
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
by Granules Consumer Health Inc.
Reason
Label mix-up: Carton incorrectly labeled.
Recall initiated
July 18, 2024
Reported by FDA
August 14, 2024
Distribution
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
by Dr. Reddy's Laboratories, Inc.
Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10.
by Eugia US LLC
Reason
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
by FDC Limited
Reason
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
by Endo Pharmaceuticals, Inc.
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
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.
