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

FDA recall notice · announced May 31, 2017 · Strides Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: U.S.A. Nationwide
Lot/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
Quantity: 127,517 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.