RecallRadar

FDA Drug recall D-0702-2022

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

On 2022-03-30 the FDA classified a Class II recall of Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810… by Teligent Pharma, citing cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0702-2022
ClassificationClass II
Statusterminated
Initiated2022-03-15
Published2022-03-30
Last updated2026-09-13 11:52 UTC
CompanyTeligent Pharma
DistributionUS

Product

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.

Reason

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

Identifiers

code_infoBatch: 15725, Exp. 6/30/2022; 16113, Exp. 10/31/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0702-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.