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
Reported: April 10, 2019 Initiated: March 28, 2019 #D-1080-2019
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 2,796 bottles
- Distribution
- AR and MS
- Location
- Lake Forest, IL
Frequently Asked Questions
What product 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. Recalled by Akorn, Inc.. Units affected: 2,796 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2019. Severity: Low. Recall number: D-1080-2019.
Related Recalls
CPSC Moderate
Huaker Magnetic Balls and Rods Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violates the Small Ba…
Shenzhen Huakechuang Technology Co. Ltd., dba Huaker, of China · 2026-02-19
CPSC Moderate
JJGoo LED Balloon Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Sta…
Shenzhen Yimu Technology Co., Ltd. dba JJGoo, of China · 2026-02-19
CPSC Moderate
Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labe…
Joly's LLC, of Orlando, Florida · 2026-02-19
CPSC Moderate
Prismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Sta…
Prismatic 3D Prints LLC of Loveland, Colorado · 2026-02-19
CPSC Moderate
SAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory …
Shenzhenshilonghuaqujialebeibaihuoshanghang (Jialebei Department Store, Longhua District, Shenzhen) dba Samit Outdoor, of China · 2026-02-19