Reported May 31, 2017 · Terminated
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076…
Strides Pharma Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Strides Pharma INC · 2 Tower Center Blvd Ste 1102 · East Brunswick, NJ · 08816-1100
Is this the product you have?
- Benzonatate capsules, 200 mg, 100-count bottle, Rx only
- Manufactured byStrides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
- Lot codes and dates
Lot #: 722507572250767225077722507872250797225080 Exp 7/20177225180722518172253227225323Exp 8/20177225649A7225650A7225651A7225652A7225653A7225654AExp 9/2017
- Amount recalled
- 127,517 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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