Recalls / Class III
Class IIID-1080-2019
Product
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
- Affected lot / code info
- Lot#: 356527, Exp 3/19
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 2,796 bottles
- Distribution pattern
- AR and MS
Timeline
- Recall initiated
- 2019-03-28
- FDA classified
- 2019-04-04
- Posted by FDA
- 2019-04-10
- Terminated
- 2020-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1080-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.