FDA-Drug2019-11-20Class II
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
KVK-Tech, Inc.
Hazard
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Sold states
Nationwide within the United States
Affected count
1534 bottles
Manufactured in
110 Terry Dr, N/A, Newtown, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0532-2020Don't want to check this manually?
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