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Class III: unlikely to cause harmTerminated

Akorn Nystatin Oral Suspension Recall

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TEC…

Akorn, Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
Apr 10, 2019
Recall ID
D-1080-2019
Check your lot numberHow we source this data

Summary

Akorn recalled Nystatin Oral Suspension starting Mar 28, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1080-2019 on Apr 10, 2019. Reason: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Product description

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16

Lot numbers, UPCs & expiration codes

Lot#: 356527, Exp 3/19

Where it was sold

AR and MS

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-1080-2019
Classification
Class III
Status
Terminated
Recall initiated
Mar 28, 2019
FDA report date
Apr 10, 2019
Quantity
2,796 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-1080-2019, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
82510
Address
1925 W Field Ct Ste 300
Code information
Lot#: 356527, Exp 3/19
Postal code
60045-4862
Report date
Apr 10, 2019
Product type
Drugs
Recall number
D-1080-2019
Classification
Class III
Recalling firm
Akorn, Inc.
Product quantity
2,796 bottles
Termination date
Apr 22, 2020
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Distribution pattern
AR and MS
Recall initiation date
Mar 28, 2019
Initial firm notification
Letter
Center classification date
Apr 4, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1080-2019, published Apr 10, 2019. 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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