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
Reported: May 17, 2017 Initiated: March 28, 2017 #D-0703-2017
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
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 49,089 bottles
- Distribution
- Nationwide
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 49,089 bottles.
Why was this product recalled? ▼
Failed Stability Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 17, 2017. Severity: Low. Recall number: D-0703-2017.
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