Home / Recalls / Mayne Pharma Inc / D-1129-2018

D-1129-2018 Class III Terminated

Recalled by Mayne Pharma Inc — Greenville, NC

Recall Details

Product Type
Drugs
Report Date
September 5, 2018
Initiation Date
August 21, 2018
Termination Date
May 19, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6456 bottles

Product Description

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.

Reason for Recall

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 Pattern

Nationwide in the USA.

Code Information

Lot: FG01517, Exp. 12/31/2019

Other recalls by Mayne Pharma Inc

  • D-1152-2022 Class II — Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per C (June 9, 2022)
  • D-0387-2022 Class II — Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, D (January 14, 2022)
  • D-0998-2020 Class II — Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne P (March 2, 2020)
  • D-0616-2018 Class III — Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Ph (March 21, 2018)
  • D-0098-2018 Class II — Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distribute (November 9, 2017)