Multi-event April 2015 FDA Recall Drug by Tarmac Products, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Tarmac Products, Inc. on April 16, 2015 for the product Drug. The FDA reported the reason for recall as products failed the antimicrobial effectiveness test. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-967-2015 TERMINATED D-966-2015 TERMINATED D-968-2015 TERMINATED

Recall Number: D-967-2015

Reason for Recall
Products failed the Antimicrobial Effectiveness Test
Initiated
04-16-2015
Reported
04-29-2015
Quantity
104,810 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71031
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.
Tarmac Products, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide to 13 Walgreen Distribution Centers and Pharmacies.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2017
Product Description About Product Description
Full technical description of the product.
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)

Batch or Lot Expiration Information

Lot# : 7568 (Refer to 13F0007), Exp 04/15; 7569 (Refer to 13F0008), Exp 05/15; 7618 (Refer to 13G0013), 7619 (Refer to 13F0013), Exp 07/15; 7620 (Refer to 13I0001), Exp 08/15 NDC 0363-0050-01.

Recall Number: D-966-2015

Reason for Recall
Products failed the Antimicrobial Effectiveness Test
Initiated
04-16-2015
Reported
04-29-2015
Quantity
41,743 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71031
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.
Tarmac Products, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide to 13 Walgreen Distribution Centers and Pharmacies.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2017
Product Description About Product Description
Full technical description of the product.
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle,

Batch or Lot Expiration Information

Lot# : 7579 (Refer to 13G0001) and
Lot# 7580 (Refer to 13G0003), Exp 06/15

Recall Number: D-968-2015

Reason for Recall
Products failed the Antimicrobial Effectiveness Test.
Initiated
04-16-2015
Reported
04-29-2015
Quantity
16,248 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71031
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.
Tarmac Products, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide to 13 Walgreen Distribution Centers and Pharmacies.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2017
Product Description About Product Description
Full technical description of the product.
Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle

Batch or Lot Expiration Information

Lot# : 7730 (Refer to 14B0001), Exp 10/15