Recalls / Class II
Class IID-1060-2020
Product
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
- Brand name
- Nystatin
- Generic name
- Nystatin
- Active ingredient
- Nystatin
- Route
- Oral
- NDCs
- 0121-0810, 0121-4810
- FDA application
- ANDA203621
- Affected lot / code info
- Lot: BE85, Exp. 11/2020
Why it was recalled
SubPotent Drug: Low out-of-specification results for assay testing.
Recalling firm
- Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Manufacturer
- Pharmaceutical Associates, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Perimeter Rd, N/A, Greenville, South Carolina 29605-5252
Distribution
- Quantity
- 7416 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2020-03-19
- FDA classified
- 2020-03-25
- Posted by FDA
- 2020-04-01
- Terminated
- 2021-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1060-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.