Teva Pharmaceuticals USA recalls PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By:…

Recall date

March 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0703-2017

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide

Why it was recalled

Failed Stability Specifications

Class III means the product violates regulations but is not likely to cause harm.

What 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