FDA-Drug2022-03-30Class II

Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.

Teligent Pharma, Inc.
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
31,489 tubes
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0702-2022

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