Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

FDA recall notice · announced May 26, 2021 · Kvk-tech

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot: 15684A, Exp 7/2021
Quantity: 17,096 bottles
Status: Terminated
Products in this recall event:
- Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03 (D-0386-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.