Class II · Moderate risk
Orphenadrine Citrate Extended-Release Tablets
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
National Drug Code
Is NDC 0185-0022-10 recalled?
Orphenadrine Citrate
Yes — this exact package was recalled
1 FDA recall names the code 0185-0022-10 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Orphenadrine Citrate
- Strength
- ORPHENADRINE CITRATE 100 mg/1
- Form
- Tablet, Extended Release · Oral
- Labeler
- Sandoz Inc
- Type
- Human Prescription Drug
- Product code
- 0185-0022
Recalls naming this package
Class III · Low risk
Orphenadrine Citrate Extended Release Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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