Drug recall D-0858-2017
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
Reason for recall
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Lots and codes
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
Recall details
- Recalling firm
- Strides Pharma INC, East Brunswick, NJ
- Quantity
- 127,517 bottles
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 9, 2017
- Terminated
- December 22, 2017
Related products
- Benzonatate – drug information
- NDC 64380-713 Benzonatate · Benzonatate 200 mg/1 · Strides Pharma Science Limited
- NDC 64380-712 Benzonatate · Benzonatate 100 mg/1 · Strides Pharma Science Limited