Recalls / Class III
Class IIID-0703-2017
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
- Affected lot / code info
- Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 49,089 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-28
- FDA classified
- 2017-05-11
- Posted by FDA
- 2017-05-17
- Terminated
- 2017-10-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0703-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.