FDAFDA · Food and drugs·Recall number D-1609-2014
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
Published October 1, 2014 · Recall initiated: April 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Corp.
- Distributor
- Nationwide.
- Lot
- Lot # KM4951; Exp. 04/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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