D-966-2015 Class II Terminated

Recalled by Tarmac Products, Inc. — Miami Gardens, FL

FDA drug recall D-966-2015 was initiated by Tarmac Products, Inc. on April 16, 2015 and is designated Class II. Reason for recall: Products failed the Antimicrobial Effectiveness Test The recall status is terminated (terminated March 3, 2017). Affected quantity: 41,743 bottles.

Recall Details

Product Type
Drugs
Report Date
April 29, 2015
Initiation Date
April 16, 2015
Termination Date
March 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41,743 bottles

Product Description

Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle,

Reason for Recall

Products failed the Antimicrobial Effectiveness Test

Distribution Pattern

Nationwide to 13 Walgreen Distribution Centers and Pharmacies.

Code Information

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