Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Reported: April 13, 2022 Initiated: March 21, 2022 #D-0753-2022
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.
Reason for Recall
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Details
- Recalling Firm
- Sandoz, Inc
- Units Affected
- 7908 bottles(790,800 extended release tablets)
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.. Recalled by Sandoz, Inc. Units affected: 7908 bottles(790,800 extended release tablets).
Why was this product recalled? ▼
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0753-2022.
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