Reported Mar 30, 2022 · Terminated
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL)…
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 Lotion0.1%packaged in a) 2 fl oz (59 mL) bottlesNDC 52565-087-02b) 4 fl oz (118 mL) bottlesNDC 52565-087-04Rx only
- Manufactured byTeligent Pharma, Inc., Buena, NJ 08310
- Lot codes and dates
- Batch
a) 16293Exp. 1/31/20231643616451Exp. 2/28/2023b) 15105Exp. 2/28/2022152901529115292Exp. 3/31/202216293Exp. 1/31/2023164361645116472Exp. 2/28/2023
- Batch
- Amount recalled
- 30,497 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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