Why it was recalled
Failed Dissolution Specifications
Product description
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Lot numbers, UPCs & expiration codes
Lot#: M300652 and M300651, exp. Dec 2024
Where it was sold
Nationwide in the USA.
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-0038-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2023
- FDA report date
- Oct 11, 2023
- Quantity
- 7,248 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0038-2024, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93100
- Address
- 73 Route 31 N
- Code information
- Lot#: M300652 and M300651, exp. Dec 2024
- Postal code
- 08534-3601
- Report date
- Oct 11, 2023
- Product type
- Drugs
- Recall number
- D-0038-2024
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 7,248 bottles
- Termination date
- Aug 6, 2025
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Sep 21, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 4, 2023