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Class II Recall
Teligent Pharma, Inc.
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.
Classification
Class II
Status
Terminated
Lot
Batch: 15725, Exp. 6/30/2022; 16113, Exp. 10/31/2022
Date
2022-03-30
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.