FDAClass IINovember 20, 2019

Hydrocodone Bitartrate and Homatropine Methlybromide recall

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…

Why was Hydrocodone Bitartrate and Homatropine Methlybromide recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
KVK-Tech, Inc.
Quantity
1534 bottles
Distribution
Nationwide within the United States
Recall date
November 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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