Reported Jul 1, 2020 · Terminated
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories,…
Crown Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Crown Laboratories · 349 Lafe Cox Dr · Johnson City, TN · 37604-7469
Is this the product you have?
Nystatin CreamUSP 100000 units per gram30 gramsRx Only
- Manufactured and Distributed byCrown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30
- Lot codes and dates
- Lot
Y0378AEXP 07/2021
- Lot
- Amount recalled
- 62,274 tubes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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