Hydrocodone Bitartrate and Homatropine Methlybromide recall: Impurity Out of Spec
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…
Why was Hydrocodone Bitartrate and Homatropine Methlybromide recalled?
Failed Impurities/Degradation Specifications
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: 15684A, Exp 7/2021
- 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…
- Recalling firm
- KVK-Tech, Inc.
- Quantity
- 17,096 bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- May 26, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)