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Class III: unlikely to cause harmTerminated

Teva Pharmaceuticals PrednisoLONE Oral Solution Recall

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

Teva Pharmaceuticals USA · North Wales, PA

Risk level
Class III
Reported by FDA
May 17, 2017
Recall ID
D-0703-2017
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled PrednisoLONE Oral Solution starting Mar 28, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0703-2017 on May 17, 2017. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

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

Lot numbers, UPCs & expiration codes

Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0703-2017
Classification
Class III
Status
Terminated
Recall initiated
Mar 28, 2017
FDA report date
May 17, 2017
Quantity
49,089 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0703-2017, exactly as published.

Show all FDA fields
City
North Wales
State
PA
Status
Terminated
Country
United States
Event ID
76871
Address
1090 Horsham Rd
Code information
Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17
Postal code
19454-1505
Report date
May 17, 2017
Product type
Drugs
Recall number
D-0703-2017
Classification
Class III
Recalling firm
Teva Pharmaceuticals USA
Product quantity
49,089 bottles
Termination date
Oct 24, 2017
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Mar 28, 2017
Initial firm notification
Letter
Center classification date
May 11, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0703-2017, published May 17, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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