Drug product
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
D-0430-2015
Product summary
- Event
- Event 70320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2284 cartons (100 individual unit doses per carton)
- Official record key
drug-enforcement:D-0430-2015
Official wording
Reason: Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Code information: AHP lot number 145513, exp 6/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules