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, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Reported: July 30, 2014 Initiated: July 11, 2014 #D-1445-2014
Product Description
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, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Reason for Recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 781,000 extended release tablets
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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, Manufactured by Sandoz Inc., Princeton, NJ 08540.. Recalled by Sandoz Inc. Units affected: 781,000 extended release tablets.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2014. Severity: Low. Recall number: D-1445-2014.
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