Drug product
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
D-0858-2017
Product summary
- Event
- Event 77311
- Status
- Terminated
- Classification
- Class III
- Quantity
- 127,517 bottles
- Official record key
drug-enforcement:D-0858-2017
Official wording
Reason: Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Code information: Lot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification