Medique Pain-Off 250 mg recalled over manufacturing violations

Recall date

December 6, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medique Products recalls Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets p…

Recall number

D-0390-2022

FDA classification

Class II

Brand / firm

Medique Products

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.