Sandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures
Sandoz Inc. is recalling Orphenadrine Citrate Extended Release Tablets because they failed dissolution specifications during stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Sandoz Inc. is recalling Orphenadrine Citrate Extended Release Tablets, 100 mg, in 100-count and 1000-count bottles. The recall involves approximately 781,000 tablets distributed nationwide. The affected lots are DM1316 and DM1318, both with an expiration date of 05/16.
The recall was initiated because the product was found to be out of specification (OOS) during stability testing, specifically regarding dissolution. This means the tablets may not release the medication as intended.
Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
- Brand
- ORPHENADRINE CITRATE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 781,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # DM1316
- Exp. 05/16 Lot # DM1318
- Exp. 05/16
Distribution
Distributed nationwide across the United States.
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