Reported Oct 22, 2014 · Terminated
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC,…
Valeant Pharmaceuticals International
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Valeant Pharmaceuticals International · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
- Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only
- Manufactured forOnset Dermatologics, LLC, Cumberland
- RI 02864 ByFerndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
- Lot codes and dates
Lot number 13052BExp. 03/2015NDC16781-382-15
- Amount recalled
- 1663 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
- PR
Why it was recalled
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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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