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Recall Observatory FDA recall evidence

Drug product

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

D-966-2015

April 16, 2015

Class II

Product summary

Firm
Tarmac Products, Inc.
Event
Event 71031
Status
Terminated
Classification
Class II
Quantity
41,743 bottles
Official record key
drug-enforcement:D-966-2015

Official wording

Reason: Products failed the Antimicrobial Effectiveness Test

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

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