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Recall Observatory FDA recall evidence

Drug 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

D-1050-2017

March 30, 2017

Class II

Product summary

Firm
Bayer HealthCare Pharmaceuticals, Inc.
Event
Event 77484
Status
Terminated
Classification
Class II
Quantity
24,672 24-count cartons
Official record key
drug-enforcement:D-1050-2017

Official wording

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

Code information: BTAHDG0; Exp. 04/19

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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