Why it was recalled
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: Y0378, EXP 07/2021
Where it was sold
Distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1339-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 35,931 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Crown Laboratories
Original FDA data
Every field from FDA enforcement report D-1339-2020, exactly as published.
Show all FDA fields
- City
- Johnson City
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 85833
- Address
- 349 Lafe Cox Dr
- Code information
- Lot: Y0378, EXP 07/2021
- Postal code
- 37604-7469
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1339-2020
- Classification
- Class II
- Recalling firm
- Crown Laboratories
- Product quantity
- 35,931 tubes
- Termination date
- Nov 5, 2021
- Reason for recall
- Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Jun 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2020