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Recall Observatory FDA recall evidence

Drug product

Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

D-0591-2018

March 07, 2018

Class II

Product summary

Firm
American Pharmaceutical Ingredients LLC
Event
Event 79420
Status
Terminated
Classification
Class II
Quantity
21 g
Official record key
drug-enforcement:D-0591-2018

Official wording

Reason: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Code information: Lot 012517-1R

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry