Recalls / Class II
Class IID-0824-2020
Product
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) 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
- Lots: BB70, BB71 Exp. May 2020
Why it was recalled
Subpotent: Out of specification for assay at the 12-month time point.
Recalling firm
- Firm
- 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
- 6288 16 oz bottles
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2020-01-14
- FDA classified
- 2020-02-03
- Posted by FDA
- 2020-02-05
- Terminated
- 2021-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0824-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.