Reported May 17, 2017 · Terminated

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

Teva Pharmaceuticals USA

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505

Is this the product you have?

  • PrednisoLONE Oral Solution USP, 15 mg/5mL
  • alcohol content5%(v/v) 240 mL bottle, Rx Only
  • Manufactured in Canada ByCONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6
  • Manufactured ForTEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Lot codes and dates
    • Lot # 94358
    • Exp. 05/17 Lot # 94920A
    • Exp. 07/17 Lot # 97083A
    • Exp. 12/17
Amount recalled
49,089 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 24, 2017 · Data as of Sep 19, 5:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.