Recalls / Class III
Class IIID-0865-2018
Product
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
- Brand name
- Nystatin
- Generic name
- Nystatin
- Active ingredient
- Nystatin
- Route
- Oral
- NDCs
- 0121-0810, 0121-4810
- FDA application
- ANDA203621
- Affected lot / code info
- Lot: B5B8 Exp. 07/2019
Why it was recalled
Resuspension problems: Out of specification for appearance and resuspendability.
Recalling firm
- Firm
- Pharmaceutical Associates Inc
- Manufacturer
- Pharmaceutical Associates, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Delaware St, N/A, Greenville, South Carolina 29605-5823
Distribution
- Quantity
- 275400 cups
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-05-29
- FDA classified
- 2018-06-13
- Posted by FDA
- 2018-06-13
- Terminated
- 2020-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0865-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.