Recalls / Class II
Class IID-0753-2022
Product
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
- Brand name
- Orphenadrine Citrate
- Generic name
- Orphenadrine Citrate
- Active ingredient
- Orphenadrine Citrate
- Route
- Oral
- NDC
- 0185-0022
- FDA application
- ANDA040327
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Recalling firm
- Firm
- Sandoz, Inc
- Manufacturer
- Sandoz Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 7908 bottles(790,800 extended release tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2022-03-21
- FDA classified
- 2022-04-06
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0753-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.