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Recall Observatory FDA recall evidence

Drug product

Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03

D-1057-2016

May 05, 2016

Class III

Product summary

Firm
KVK-Tech, Inc.
Event
Event 74086
Status
Terminated
Classification
Class III
Quantity
9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A
Official record key
drug-enforcement:D-1057-2016

Official wording

Reason: Discoloration: presence of scuffing marks on tablets.

Code information: Lot #: 12825 A, 12937A, Exp 8/18

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration: presence of scuffing marks on tablets.