FDA Drug Recalls

Recalls / Class II

Class IID-1051-2017

Product

Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085

Affected lot / code info
BTAHGR0; Exp. 05/19 BTAHGR1; Exp. 05/19 BTAHGR2; Exp. 05/19 BTAJ0K3; Exp. 07/19

Why it was recalled

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Recalling firm

Firm
Bayer HealthCare Pharmaceuticals, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
36 Columbia Rd, N/A, Morristown, New Jersey 07960-4526

Distribution

Quantity
56,064 36-count cartons
Distribution pattern
Nationwide

Timeline

Recall initiated
2017-03-30
FDA classified
2017-08-01
Posted by FDA
2017-08-09
Terminated
2020-01-08
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1051-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls