Why it was recalled
Failed Dissolution Specifications
Product description
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Lot numbers, UPCs & expiration codes
Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
Where it was sold
Nationwide, including Puerto Rico.
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-0996-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 21, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 14,448 bottles
- Recall type
- N/A
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0996-2019, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 82144
- Address
- 1101 C Ave W
- Code information
- Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
- Postal code
- 47274-3342
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-0996-2019
- Classification
- Class III
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 14,448 bottles
- Termination date
- Nov 6, 2020
- Reason for recall
- Failed Dissolution Specifications
- Product description
- Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
- Distribution pattern
- Nationwide, including Puerto Rico.
- Recall initiation date
- Feb 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2019