Drug & medication recalls Moderate risk

Lidocaine Cream 4% recalled over manufacturing violations

Recall date
March 15, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Teligent Pharma, Inc. recalls Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Liv…
Recall number
D-0704-2022
FDA classification
Class II
Brand / firm
Teligent Pharma, Inc.
Sold / distributed
Nationwide in the USA and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.

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