Reported Nov 20, 2019 · Terminated

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd.…

KVK-Tech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: KVK-Tech, Inc. · 110 Terry Dr · Newtown, PA · 18940-3427

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: 14375A
    • Exp. date 2019-DEC
    • 14398A
    • Exp. date 2020-JAN
Amount recalled
1534 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 16, 2020 · Data as of Sep 19, 5:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.