Class II
Terminated
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
This recall has been terminated (originally issued August 18, 2021).
- Recall Initiated
- July 29, 2021
- Posted
- August 18, 2021
- Recall Number
- D-0721-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
- Firm Location
- Greenville, SC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
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