Mayne Pharma recalls

Mayne Pharma appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2022-06-29.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Phar…
  FDA Drug · Class II · 2022-06-29 · Mayne Pharma
  Reason: Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
• Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-…
  FDA Drug · Class II · 2022-01-26 · Mayne Pharma
  Reason: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
• Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834
  FDA Drug · Class II · 2020-03-18 · Mayne Pharma
  Reason: Product Mix-Up: A foreign tablet was found in bottle.
• Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC…
  FDA Drug · Class III · 2018-09-05 · Mayne Pharma
  Reason: 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.
• Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834
  FDA Drug · Class III · 2018-04-11 · Mayne Pharma
  Reason: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
• Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
  FDA Drug · Class II · 2017-12-06 · Mayne Pharma
  Reason: Failed Dissolution Specifications.