Multi-event March 2017 FDA Recall Drug by Bayer Healthcare Pharmaceuticals, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Bayer Healthcare Pharmaceuticals, Inc. on March 30, 2017 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1051-2017 TERMINATED D-1050-2017 TERMINATED D-1044-2017 TERMINATED

Recall Number: D-1051-2017

Reason for Recall
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Initiated
03-30-2017
Reported
08-09-2017
Quantity
56,064 36-count cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77484
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer HealthCare Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2020
Product Description About Product Description
Full technical description of the product.
Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085

Batch or Lot Expiration Information

Lot# BTAHGR0; Exp. 05/19 BTAHGR1; Exp. 05/19 BTAHGR2; Exp. 05/19 BTAJ0K3; Exp. 07/19

Recall Number: D-1050-2017

Reason for Recall
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Initiated
03-30-2017
Reported
08-09-2017
Quantity
24,672 24-count cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77484
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer HealthCare Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# BTAHDG0; Exp. 04/19

Recall Number: D-1044-2017

Reason for Recall
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Initiated
03-30-2017
Reported
08-09-2017
Quantity
1,067,520 12-count cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77484
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer HealthCare Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# BTAH340; Exp. 02/19 BTAHCP0; Exp. 04/19 BTAHLW0; Exp. 06/19 BTAHLX0; Exp. 08/19 BTAHP10; Exp 08/19