FDAFDA · Food and drugs·Recall number D-0858-2017
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
Published May 31, 2017 · Recall initiated: May 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BENZONATATE
- Manufacturer
- Strides Pharma INC
- Distributor
- U.S.A. Nationwide
- UPC
- 0364380713074
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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