Strides Pharma INC recalls Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 Indi…
- Recall date
- May 9, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0858-2017
- FDA classification
- Class III
- Brand / firm
- Strides Pharma INC
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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