Recalls / Class III
Class IIID-0858-2017
Product
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
- Brand name
- Benzonatate
- Generic name
- Benzonatate
- Active ingredient
- Benzonatate
- Route
- Oral
- NDCs
- 64380-712, 64380-713
- FDA application
- ANDA091133
- Affected lot / code info
- 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
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Recalling firm
- Firm
- Strides Pharma INC
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 127,517 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2017-05-09
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2017-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0858-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.