Drug 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
D-1044-2017
Product summary
- Event
- Event 77484
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,067,520 12-count cartons
- Official record key
drug-enforcement:D-1044-2017
Official wording
Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Code information: BTAH340; Exp. 02/19 BTAHCP0; Exp. 04/19 BTAHLW0; Exp. 06/19 BTAHLX0; Exp. 08/19 BTAHP10; Exp 08/19
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.