Mayne Pharma recalls
FDA enforcement reports naming Mayne Pharma Inc as the recalling firm.
- Recall reports
- 7
- Class I (serious)
- 0
- Most recent report
- Jun 29, 2022
- Jun 29, 2022Clonidine Transdermal System, USP 0Drug · Mayne Pharma IncDefective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.Class II
- Jan 26, 2022Lexette (halobetasol propionate) Topical Foam, 0Drug · Mayne Pharma IncCGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.Class II
- Mar 18, 2020Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma,…Drug · Mayne Pharma IncProduct Mix-Up: A foreign tablet was found in bottle.Class II
- Sep 5, 2018Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manu…Drug · Mayne Pharma IncLabeling: 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
- Apr 11, 2018Fabior (tazarotene) Foam, 0Drug · Mayne Pharma IncSuperpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.Class III
- Dec 6, 2017Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Pe…Drug · Mayne Pharma IncFailed Dissolution Specifications.Class II
- Jan 27, 2016Bromfenac Ophthalmic Solution 0Drug · Mayne Pharma UsaLack of Assurance of Sterility: Failed preservative effectiveness testClass II