Nystatin Oral Suspension recall: CGMP Deviations
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
Why was Nystatin Oral Suspension recalled?
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
- Product
- 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
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Quantity
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
- Distribution
- Distributed Nationwide in the USA
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)