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
Reported: May 31, 2017 Initiated: May 9, 2017 #D-0858-2017
Product Description
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.
Details
- Recalling Firm
- Strides Pharma INC
- Units Affected
- 127,517 bottles
- Distribution
- U.S.A. Nationwide
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product 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. Recalled by Strides Pharma INC. Units affected: 127,517 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2017. Severity: Low. Recall number: D-0858-2017.
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