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FDAMarch 15, 2022drug

Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

What to do

FDA enforcement status: Terminated

Brands named

teligent pharmateligent

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04. — Recall Details · AllClear