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Recall Observatory FDA recall evidence

Drug product

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10

D-0110-2018

December 18, 2017

Class III

Product summary

Firm
Osmotica Pharmaceutical Corp
Event
Event 78764
Status
Terminated
Classification
Class III
Quantity
10064 bottles
Official record key
drug-enforcement:D-0110-2018

Official wording

Reason: Subpotent Drug

Code information: Lot #: 170027A, Exp. 02/2019

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent