Procaps S.A. de C.V. Issues Alert on Undeclared Peg 40 Hydrogenated Castor Oil in Laboratorios Lopez’s Bacaolinita®

COMPANY ANNOUNCEMENT

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Link to Spanish Translation

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.

Bacaolinita was distributed to distributors in Delaware, Rhode Island, Texas, and California, and reached consumers through retail stores and online.

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).

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.

Consumers who have purchased Bacaolinita are urged to return it to the place of purchase for a full refund. Consumers with questions may contact our recall administrator at 1-561-444-8188; Monday-Friday from 8:30 AM - 5:00 PM EST or via email at [email protected].

06/07/2023

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