Analgesic Tablets Recalled

Bryant Ranch Prepack Inc, doing business as BRP Pharmaceuticals, is recalling nearly 700 bottles of butalbital, acetaminophen, and caffeine tablets because product labels failed to include the controlled substance schedule III (CIII) classification, according to the December 1, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were packaged by Bryant Ranch Prepack, Burbank, CA, and distributed throughout the United States:

• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 12-count bottles (NDC 63629-8392-09, barcode 083929152151), Lannett Company Inc, from lots 152838, 152156, 152151, 151708, 151693, 151375, 151131, and 151114 (Exp. 7/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 60-count bottles (NDC 63629-8392-03, barcode 083923152614), Lannett Company Inc, from lots 152245, 151822, 151708, 151160, and 151131 (Exp. 7/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 90-count bottles (NDC 63629-8392-04, barcode 083924152614), Lannett Company Inc, from lot 152614 (Exp. 7/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 12-count bottles (NDC 71335-1767-09, barcode 083929164865), Westminster Pharmaceuticals, from lots 164865 (Exp. 2/28/21), 162113 (Exp. 8/31/22), 160419 (Exp. 2/28/23), 160004 (Exp. 8/31/22), 155752 (Exp. 8/31/22), 154380 (Exp. 8/31/22), 153776 (Exp. 8/31/22), and 152889 (Exp. 8/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 20-count bottles (NDC 71335-1767-01, barcode 083921157837), Westminster Pharmaceuticals, from lots 157837 (Exp. 8/31/22) and 154997 (Exp. 8/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 30-count bottles (NDC 71335-1767-02, barcode 083922165687), Westminster Pharmaceuticals, from lots 165687 (Exp. 2/28/23), 160419 (Exp. 2/28/23), 160330 (Exp. 2/28/23), 159973 (Exp. 8/31/22), 159943 (Exp. 8/31/22), 159352 (Exp. 8/31/22), 159345 (Exp. 8/31/22), 158841 (Exp. 8/31/22), 155752 (Exp. 8/31/22), 152347 (Exp. 8/31/22), 152245 (Exp. 7/31/22), 152156 (Exp. 7/31/22), 152197 (Exp. 7/31/22), 151338 (Exp. 7/31/22), and 151160 (Exp. 7/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 60-count bottles (NDC 71335-1767-03, barcode 083923153776), Westminster Pharmaceuticals, from lots 162641 (Exp. 2/28/23), 154380 (Exp. 8/31/22), 153776 (Exp. 8/31/22), and 152889 (Exp. 8/31/22);
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 90-count bottles (NDC 71335-1767-04, barcode 083924152889), Westminster Pharmaceuticals, from lots 158841 (Exp 8/31/22) and 152889 (Exp 8/31/22); and
• butalbital, acetaminophen, and caffeine 50/325/40 tablets in 120-count bottles (NDC 71335-1767-07, barcode 083927153735) ,Westminster Pharmaceuticals, from lots 153776 (Exp. 8/31/22), 153735 (Exp. 8/31/22), and 152347 (Exp. 8/31/22).

Bryant Ranch Prepack voluntarily initiated the recall September 28, 2021. On November 23, 2021, the FDA designated the recall Class III. Under the recall classification, use of the tablets is not likely to cause harm.

Butalbital, acetaminophen, and caffeine tablets are available with a prescription to treat tension (or muscle contraction) headache.