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Recall Observatory FDA recall evidence

Drug product

Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.

D-1288-2020

May 22, 2020

Class II

Product summary

Firm
The Harvard Drug Group
Event
Event 85757
Status
Terminated
Classification
Class II
Quantity
16,443 cartons
Official record key
drug-enforcement:D-1288-2020

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) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification