Greenville, NC, United States
Mayne Pharma Inc recalls
5 recalls recorded since 2018, most recently on 9 June 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 9 June 2022
- Terminated
- 23 August 2023
- Reason
- Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
- Distribution
- Nationwide in the US Market
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1152-2022
- Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
Ongoing Class II Drugs
- Recall started
- 14 January 2022
- Reason
- CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0387-2022
- Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Terminated Class II Drugs
- Recall started
- 2 March 2020
- Terminated
- 28 October 2021
- Reason
- Product Mix-Up: A foreign tablet was found in bottle.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0998-2020
- Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
Terminated Class III Drugs
- Recall started
- 21 August 2018
- Terminated
- 19 May 2020
- 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.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1129-2018
- Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
Terminated Class III Drugs
- Recall started
- 21 March 2018
- Terminated
- 11 June 2020
- Reason
- Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0616-2018
- Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.