Drug product
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
D-0703-2017
Product summary
- Event
- Event 76871
- Status
- Terminated
- Classification
- Class III
- Quantity
- 49,089 bottles
- Official record key
drug-enforcement:D-0703-2017
Official wording
Reason: Failed Stability Specifications
Code information: Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications