Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Gentamicin Sulfate Cream USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDC
70512-0036-30
Compare with the code on your package — it is the most precise check available.
Drug: Gentamicin
- Recalling firm
- Teligent Pharma, Inc.
- NDC code
- 70512-036-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0702-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Gentamicin recalls
See all
Class II · Moderate risk
Gentamicin Bladder 0.08mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Gentamicin Sulfate Ointment USP 0.1%
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin Sulfate Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin 80mg/60 mL Irrigation
Lack of Assurance of Sterility
Other recalls by Teligent Pharma, Inc.
All 2022 recalls
Class II · Moderate risk
Lidocaine Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Cream 4%
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Hydrocortisone Butyrate Lotion
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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