Class III
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- March 28, 2019
- Posted
- April 10, 2019
- Recall Number
- D-1080-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,796 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Distribution
AR and MS
Lot / Code Info
Lot#: 356527, Exp 3/19
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