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Class II: temporary or reversible health riskTerminated

Akorn Sulfamethoxazole And Trimethoprim Oral Recall

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FL…

Akorn, Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
May 20, 2015
Recall ID
D-0997-2015
Check your lot numberHow we source this data

Summary

Akorn recalled Sulfamethoxazole And Trimethoprim Oral starting Mar 17, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0997-2015 on May 20, 2015. Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Product description

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Lot numbers, UPCs & expiration codes

Lot # 624271, Exp. Date 10/2015

Where it was sold

Nationwide and Puerto Rico

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-0997-2015
Classification
Class II
Status
Terminated
Recall initiated
Mar 17, 2015
FDA report date
May 20, 2015
Quantity
8,400 unit dose cups (20 mL each)
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0997-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
70743
Address
1925 W. Field Court, Suite 300
Code information
Lot # 624271, Exp. Date 10/2015
Postal code
60045
Report date
May 20, 2015
Product type
Drugs
Recall number
D-0997-2015
Classification
Class II
Recalling firm
Akorn, Inc.
Product quantity
8,400 unit dose cups (20 mL each)
Termination date
Dec 27, 2017
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Voluntary / mandated
Voluntary: Firm initiated
Product description
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Mar 17, 2015
Initial firm notification
Letter
Center classification date
May 8, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0997-2015, published May 20, 2015. 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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