Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
Reported: October 1, 2014 Initiated: April 18, 2014 #D-1609-2014
Product Description
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
Reason for Recall
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 5,397 bottles
- Distribution
- Nationwide.
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03. Recalled by Apotex Corp.. Units affected: 5,397 bottles.
Why was this product recalled? ▼
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 1, 2014. Severity: Low. Recall number: D-1609-2014.
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