Reported Mar 30, 2022 · Terminated
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC…
Teligent Pharma, Inc.
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: Teligent Pharma, Inc. · 105 Lincoln Avenue · Buena, NJ · 08310
Is this the product you have?
Hydrocortisone Butyrate Lotion 0.1%4 fl. oz. (118 mL) bottleRx only
- Distributed byMayne Pharma, Greenville, NC 27834, NDC 51862-159-04
- Lot codes and dates
- Batch
15435Exp. 3/31/202216960Exp. 5/31/2023
- Batch
- Amount recalled
- 6431 bottles
This recall covers 37 products
The agency filed one notice per product. You are reading one of them; the other 36 are below.
24 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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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