D-1080-2019 Class III Terminated
FDA drug recall D-1080-2019 was initiated by Akorn, Inc. on March 28, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. The recall status is terminated (terminated April 22, 2020). Affected quantity: 2,796 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2019
- Initiation Date
- March 28, 2019
- Termination Date
- April 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,796 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Distribution Pattern
AR and MS
Code Information
Lot#: 356527, Exp 3/19