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Recall Observatory FDA recall evidence

Drug product

Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

D0034-2015

August 07, 2014

Class II

Product summary

Firm
New Gpc Inc.
Event
Event 69206
Status
Terminated
Classification
Class II
Quantity
4320 units
Official record key
drug-enforcement:D0034-2015

Official wording

Reason: Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.

Code information: Batch Numbers: 202504, 310455

Distribution pattern: New York

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.