Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0858-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 9, 2017
- FDA report date
- May 31, 2017
- Quantity
- 127,517 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma INC
Original FDA data
Every field from FDA enforcement report D-0858-2017, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77311
- Address
- 2 Tower Center Blvd Ste 1102
- 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
- Postal code
- 08816-1100
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0858-2017
- Classification
- Class III
- Recalling firm
- Strides Pharma INC
- Product quantity
- 127,517 bottles
- Termination date
- Dec 22, 2017
- Reason for recall
- Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- May 9, 2017
- Initial firm notification
- Letter
- Center classification date
- May 23, 2017