Recalled Herbal Laxatives Contain Naproxen, Not Senna
This article was originally published in The Rose Sheet
Executive Summary
Magno-Humphries Laboratories, which has a history recalls prompted by label and formulation errors, recalls one lot of its Basic Drugs brand Sennosides 8.6 mg senna laxative tablets following a complaint that a bottle contained 220 mg tablets of the NSAID naproxen sodium.
Dietary supplements labeled as laxatives but containing an OTC pain reliever are being recalled by Magno-Humphries Laboratories Inc., which has a history of recalls prompted by label and formulation errors.
The firm on Jan. 23 announced a voluntary recall of one lot of its Basic Drugs brand 8.6 mg senna laxative tablets following a customer complaint that a bottle of the product contained Basic Drugs 220 mg tablets of naproxen sodium, a nonsteroidal anti-inflammatory drug.
Basic Drugs 8.6 mg senna laxative tablets are recalled after a customer complained a bottle contained 220 mg naproxen sodium tablets.
Magno-Humphries, in its statement posted on FDA's website, said Basic Sennosides tablets are used as a natural laxative to relieve constipation and are distributed in 100-count bottles. The lot – #352300, expiration date January 2019 – was circulated nationwide in the US through secondary distributors and sold at retail pharmacies and online.
Tignor, Ore., firm also said unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients allergic to the undisclosed ingredients or with underlying illnesses including and cardiac, gastrointestinal, hepatic and renal conditions as well as patients who recently undergone cardiac bypass graft surgery.
Most at risk are children, pregnant or nursing women and surgical patients. The firm said it has not received any reports of adverse events related to the recalled product.
Labeling mix-ups that previously prompted Magno-Humphries recalls include:
- a 1,000 IU vitamin E product labeled as containing 200 IU in 2014 (Also see "FDA Recalls For April 23, 2014" - Pink Sheet, 28 Apr, 2014.);
- some 20 supplement products in 2013 distributed with labeling in Spanish that made unapproved drug claims and with the original manufacturer's label covered by the distributor's sticker label (Also see "FDA Recalls For April 11, 2012" - Pink Sheet, 23 Apr, 2012.);
- in 2007 and 2008, private label OTC drugs with defective peel-back labels, which were tearing with a significant amount of ink transferred to the bottle and with drug-use information potentially illegible. (Also see "Chart: FDA Recalls -- Sept. 3, 2008" - Pink Sheet, 8 Sep, 2008.)