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Recall Observatory FDA recall evidence

Drug product

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

D-0532-2020

November 01, 2019

Class II

Product summary

Firm
KVK-Tech, Inc.
Event
Event 84184
Status
Terminated
Classification
Class II
Quantity
1534 bottles
Official record key
drug-enforcement:D-0532-2020

Official wording

Reason: Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Code information: Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance