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Recall Observatory FDA recall evidence

Drug product

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

D-967-2015

April 16, 2015

Class II

Product summary

Firm
Tarmac Products, Inc.
Event
Event 71031
Status
Terminated
Classification
Class II
Quantity
104,810 bottles
Official record key
drug-enforcement:D-967-2015

Official wording

Reason: Products failed the Antimicrobial Effectiveness Test

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.

Distribution pattern: Nationwide to 13 Walgreen Distribution Centers and Pharmacies.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products failed the Antimicrobial Effectiveness Test