Children’s Bacaolinita Supplement Recalled
Procaps S.A. DE C.V.’s Bacaolinita Children’s Supplement has been recalled through the FDA, effective immediately. The supplement is marketed as a vitamin supplement for children with slow growth or decreased appetite. However, the product is noted to contain an inactive ingredient, PEG 40 hydrogenated castor oil that has not been declared on the label.
PEG 40 hydrogenated castor oil is typically used during manufacturing as a surfactant, emulsifier, or cleansing agent and is not approved for internal use or consumption. Studies on the effects of the substance on the human body are limited, but some medication interactions have been noted in the past and certain sensitive individuals, such as children are at risk of anaphylactic reactions when consuming the product.
SUMMARY
Date of Recall:
Announced: June 7, 2023
Public Notification: June 7, 2023
Name(s) of Recalled Drug:
Bacaolinita
Company Name:
PROCAPS S.A. DE C.V.
Laboratorios Lopez’s
Drug Indication:
Health Supplement for Children with decreased appetite or slow growth.
Recalled Product Description
The product is sold in a dark, amber-colored, plastic, 8oz bottle within a blue box adorned with the name of the supplement and an image of two children.
Reason for Recall
No adverse reactions have been reported as of the writing of this notice. However, the consumption of PEG 40 hydrogenated castor oil can result in medication interactions and anaphylaxis, leading to possible death.
Impacts
Consumers who utilize the recalled product are at risk of an anaphylactic reaction. Symptoms of this serious reaction include:
- Clammy Skin
- Hives
- Vomiting
- Confusion
- Anxiety
- Lightheadedness
- Wheezing
- Loss of Consciousness
- Fast Heartrate
- Death
Lot information
The recalled supplement was distributed throughout Delaware, Rhode Island, Texas, and California, both online and via retail locations.
Consumers should locate the box in which the supplement is packaged to compare UPC, lot numbers, and expiration dates with the chart below. If you find your UPC, lot numbers and expiration date listed on the chart below, your supplement is affected by the recall and you will need to take additional steps in order to ensure that your health, or the health of your child is not affected and to take part in recall procedures.
| Product Description | UPC | Lot Number | Expiration Date |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1358739 | 7/14/2023 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1379697 | 11/22/2023 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1379718 | 11/22/2023 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1397103 | 3/6/2024 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1404273 | 4/19/2024 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1416127 | 6/27/2024 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1420872 | 7/26/2024 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1423729 | 8/15/2024 |
| Bacaolinita, 8 oz | 8-4152-0002-8 | 1451962 | 2/15/2025 |
Have you found that your supplement is part of the recall? Here’s what you should do:
Consumers
If you find that your lot of supplement is part of this recall, do the following:
- Call your doctor right away. Notify them of any portion that has been consumed and any symptoms that may have occurred.
- Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
- Consumers should return the product to the place of purchase for a full refund.
- Consumers may contact the manufacturer with any questions at 1-561-444-8188. They are available Mon-Fri from 8:30am to 5:00pm (EST). You can also contact them via email at recall@jmm.one.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact the manufacturer with any questions at 1-561-444-8188 or you can utilize recall@jmm.one to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact the manufacturer at 1-561-444-8188 or you can utilize recall@jmm.one to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposal of the recalled medication.
We are MedWaste Management – California’s medical waste disposal experts!
Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog in order to spread useful and practical information to help you stay safe, smart and healthy!
Call us with any questions or to start service at (866) 254-5105. We are always happy to help!
Check out our services and other great resources in the links below.
Medical Waste Disposal Services
Learn How To Properly Manage & Dispose of Household Medical Waste
Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics.
You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!