Recalls / Class II
Class IID-1044-2017
Product
Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
- Affected lot / code info
- BTAH340; Exp. 02/19 BTAHCP0; Exp. 04/19 BTAHLW0; Exp. 06/19 BTAHLX0; Exp. 08/19 BTAHP10; Exp 08/19
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
- 1,067,520 12-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-1044-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.