Orphenadrine Citrate Extended Release Tablets recall: Failed Dissolution
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only…
Why was Orphenadrine Citrate Extended Release Tablets recalled?
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
- Product
- Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only…
- Recalling firm
- Sandoz Inc
- Quantity
- 781,000 extended release tablets
- Distribution
- Nationwide
- Recall date
- July 30, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)