Class II · Moderate risk
Halobetasol Propionate Ointment 0.05% Net Wt.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Halobetasol Propionate Ointment
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
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.
Affected NDC
63739-0998-67
Compare with the code on your package — it is the most precise check available.
Drug: Halobetasol
- Recalling firm
- Teligent Pharma, Inc.
- NDC code
- 63739-998-67
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0691-2022 · 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 Halobetasol recalls
See all
Class II · Moderate risk
Halobetasol Propionate Ointment
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Halobetasol Propionate Ointment
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Lexette (halobetasol propionate)
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk
Halobetasol Propionate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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
Gentamicin Sulfate Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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