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Recall Observatory FDA recall evidence

Drug product

Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627

D-1030-2013

August 23, 2013

Class II

Product summary

Firm
Wellness Pharmacy, Inc.
Event
Event 66188
Status
Terminated
Classification
Class II
Quantity
1355 units
Official record key
drug-enforcement:D-1030-2013

Official wording

Reason: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Code information: Lot# 130605@52, Exp. 12/2/2013

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination