Class III
Terminated
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
- Company
- Strides Pharma Inc.
- Recall Initiated
- May 9, 2017
- Posted
- May 31, 2017
- Recall Number
- D-0858-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 127,517 bottles
- Firm Location
- East Brunswick, NJ, United States
Reason for Recall
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Distribution
U.S.A. Nationwide
Lot / Code Info
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
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