FDA-Drug2017-05-17Class III

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

Teva Pharmaceuticals USA
Hazard

Failed Stability Specifications

Sold states
Nationwide
Affected count
49,089 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0703-2017

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