FDA-Drug2017-05-31Class III
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
Strides Pharma INC
Hazard
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Sold states
U.S.A. Nationwide
Affected count
127,517 bottles
Manufactured in
2 Tower Center Blvd Ste 1102, East Brunswick, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0858-2017Don't want to check this manually?
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