D-0858-2017 Class III Terminated
FDA drug recall D-0858-2017 was initiated by Strides Pharma INC on May 9, 2017 and is designated Class III. Reason for recall: Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. The recall status is terminated (terminated Dec 22, 2017). Affected quantity: 127,517 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- May 9, 2017
- Termination Date
- Dec 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127,517 bottles
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.
Distribution Pattern
U.S.A. Nationwide
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0858-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026