Why it was recalled
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Product description
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Lot numbers, UPCs & expiration codes
Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023
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-0753-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 7908 bottles(790,800 extended release tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-0753-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88937
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023
- Postal code
- 08540-6243
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0753-2022
- Classification
- Class II
- Recalling firm
- Sandoz, Inc
- Product quantity
- 7908 bottles(790,800 extended release tablets)
- Termination date
- Aug 14, 2023
- Reason for recall
- CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 21, 2022
- Initial firm notification
- Press Release
- Center classification date
- Apr 6, 2022