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Recall Observatory FDA recall evidence

Drug product

Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

D-0338-2018

January 29, 2018

Class III

Product summary

Firm
Mckesson Packaging Services
Event
Event 79060
Status
Terminated
Classification
Class III
Quantity
24120 cups
Official record key
drug-enforcement:D-0338-2018

Official wording

Reason: Subpotent Drug: Out of specification for assay (stability testing)

Code information: Lot #: 0114588, Exp 10/18

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent