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Recall Observatory FDA recall evidence

Drug product

CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1

D-0113-2021

November 19, 2020

Class II

Product summary

Firm
US Pharmaceuticals Inc.
Event
Event 86868
Status
Terminated
Classification
Class II
Quantity
3312 units
Official record key
drug-enforcement:D-0113-2021

Official wording

Reason: Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.

Code information: Lot # 41C19 Exp 3/2021

Distribution pattern: Distributed in RI

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack Of CGMP