Safety Report: Bacaolinita - recalled due to Unapproved PEG-40 Hydrogenated Castor Oil, USA

United States

PROCAPS S.A. DE C.V. from San Salvador, El Salvador is voluntarily recalling Laboratorios Lopez's Bacaolinita 8 FL OZ, a dietary supplement, due to the label of the product not declaring, PEG-40 hydrogenated castor oil as an inactive ingredient on the labeling. Safety data on the oral ingestion of PEG-40 hydrogenated castor oil in humans is scarce. Although rare, it has been published that PEG can interact with other medications and in sensitized individuals may cause hypersensitivity reactions, including anaphylaxis. This product was distributed to distributors in Delaware, Rhode Island, Texas, and California, and reached consumers through retail stores and online. It is important to highlight that, to date, no adverse events have been reported by consumers of Laboratorios Lopez's Bacaolinita 8 FL OZ, a dietary supplement.

Bacaolinita is marketed in a dark amber plastic 8 Fl Oz bottle packed in a cardboard box (UPC8-4152-0002-8). Affected lots and expiration dates are: 1358739 (EXP: 7/14/2023), 1379697 (EXP: 11/22/23), 1379718 (EXP: 11/22/23), 1397103 (EXP: 3/6/24), 1404273 (EXP: 4/19/24), 1416127 (EXP: 6/27/24), 1420872 (EXP: 7/26/24), 1423729 (EXP: 8/15 /24), 1451962 (EXP: 2/15/25).

Consumers who have purchased Bacaolinita are urged to return it to the place of purchase for a full refund.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: PROCAPS S.A. DE C.V.
Brand name: Bacaolinita
Product recalled: Food and Beverage Safety/Unapproved Ingredient
Reason of the recall: Unapproved PEG-40 Hydrogenated Castor Oil
FDA Recall date: June 07, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/procaps-sa-de-cv-issues-alert-undeclared-peg-40-hydrogenated-castor-oil-laboratorios-lopezs