Why it was recalled
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Product description
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Lot numbers, UPCs & expiration codes
M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Where it was sold
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-0098-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Oct 19, 2023
- FDA report date
- Nov 15, 2023
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0098-2024, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 93260
- Address
- 73 Route 31 N
- Code information
- M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
- Postal code
- 08534-3601
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0098-2024
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Reason for recall
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 19, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 8, 2023