FDA Drug Recalls

Recalls / Class II

Class IID-1050-2017

Product

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048

Affected lot / code info
BTAHDG0; Exp. 04/19

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
24,672 24-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-1050-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.