Recalls / Class II
Class IID-1339-2020
Product
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
- Brand name
- Nystatin Cream
- Generic name
- Nystatin Cream
- Active ingredient
- Nystatin
- Route
- Topical
- NDC
- 0316-0221
- FDA application
- ANDA207733
- Affected lot / code info
- Lot: Y0378, EXP 07/2021
Why it was recalled
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Recalling firm
- Firm
- Crown Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 349 Lafe Cox Dr, N/A, Johnson City, Tennessee 37604-7469
Distribution
- Quantity
- 35,931 tubes
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2020-06-10
- FDA classified
- 2020-06-24
- Posted by FDA
- 2020-07-01
- Terminated
- 2021-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1339-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.