Medique Products: Drug Recall

Recall #D-0390-2022 · 12/06/2021

Class II: Risk

Recall Details

Recall Number: D-0390-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Medique Products
Status: Terminated
Date Initiated: 12/06/2021
Location: Fort Myers, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,630,118 tablets

Reason for Recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Product Description

Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.

Distribution Pattern

Nationwide in the USA

Other Recalls by Medique Products

Class II: Risk 12/06/2021

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II: Risk 12/06/2021

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

View all recalls by Medique Products →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.