D-0386-2021 Class III Terminated
FDA drug recall D-0386-2021 was initiated by KVK-Tech, Inc. on April 27, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated October 5, 2022). Affected quantity: 17,096 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- April 27, 2021
- Termination Date
- October 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,096 bottles
Product Description
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
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot: 15684A, Exp 7/2021