D-1338-2020 Class II Terminated
FDA drug recall D-1338-2020 was initiated by Crown Laboratories on June 10, 2020 and is designated Class II. Reason for recall: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. The recall status is terminated (terminated November 5, 2021). Affected quantity: 62,274 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- June 10, 2020
- Termination Date
- November 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62,274 tubes
Product Description
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30
Reason for Recall
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Distribution Pattern
Distributed Nationwide in the USA.
Code Information
Lot: Y0378A, EXP 07/2021