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D-967-2015 Class II Terminated

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

FDA drug recall D-967-2015 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: 104,810 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: 104,810 bottles

Product Description

Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)

Reason for Recall

Products failed the Antimicrobial Effectiveness Test

Distribution Pattern

Nationwide to 13 Walgreen Distribution Centers and Pharmacies.

Code 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.