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Recall Observatory FDA recall evidence

Drug product

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

D-1274-2020

May 13, 2020

Class II

Product summary

Firm
West-Ward Columbus Inc
Event
Event 85555
Status
Terminated
Classification
Class II
Quantity
68,376 bottles
Official record key
drug-enforcement:D-1274-2020

Official wording

Reason: Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

Code information: Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification