D-0703-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 17, 2017
- Initiation Date
- March 28, 2017
- Termination Date
- October 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,089 bottles
Product Description
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Reason for Recall
Failed Stability Specifications
Distribution Pattern
Nationwide
Code Information
Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17