Recalls / Class II
Class IID-0721-2021
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
- Brand name
- Nystatin
- Generic name
- Nystatin
- Active ingredient
- Nystatin
- Route
- Oral
- NDC
- 0121-0868
- FDA application
- ANDA203621
- Affected lot / code info
- Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
Why it was recalled
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Recalling firm
- Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Perimeter Rd, N/A, Greenville, South Carolina 29605-5252
Distribution
- Quantity
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-12
- Posted by FDA
- 2021-08-18
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0721-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.