FDA Drug recall D-0753-2022
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-…
- FDA Drug
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-… by Sandoz, citing CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0753-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-21 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Reason
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Identifiers
| ndc | 0185-0022-10 |
|---|---|
| ndc | 0185-0022-01 |
| code_info | Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 L…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Sandoz
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,…
FDA Drug · Class III · 2026-06-24 · Sandoz - Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fa…
FDA Drug · Class II · 2025-09-24 · Sandoz - Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgiu…
FDA Drug · Class II · 2025-09-17 · Sandoz - Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sand…
FDA Drug · Class I · 2025-07-09 · Sandoz - Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austr…
FDA Drug · Class I · 2025-07-09 · Sandoz
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0753-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.