FDA recall D-1044-2017

Bayer HealthCare Pharmaceuticals, Inc. · Class II · 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

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-03-30
Report date
2017-08-09
Termination date
2020-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2017