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.
Lexette (halobetasol propionate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Affected NDC
51862-0604-50
Compare with the code on your package — it is the most precise check available.
Drug: Halobetasol
- Recalling firm
- Mayne Pharma Inc
- NDC code
- 51862-604-50
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0387-2022 · 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.
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
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 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 Mayne Pharma Inc
All 2022 recalls
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Product Mix-Up: A foreign tablet was found in bottle.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class III · Low risk
Fabior (tazarotene)
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
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