Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, R
See all recalls from Sandoz, Inc →Recalled Product
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Hazard / Issue
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Issued by
FDA
Distribution: Nationwide (United States)
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
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Orphenadrine Citrate Extended-Release Tablets, →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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