Akorn, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityvill…
- Recall date
- March 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1080-2019
- FDA classification
- Class III
- Brand / firm
- Akorn, Inc.
- Sold / distributed
- AR and MS
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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