The U.S. Food and Drug Administration (FDA) classified the recall as a Class II event on May 19. A combined total of about 4,196 bottles of Vitamin B-Complex and Vitamin C & Folic Acid Dietary Supplement, manufactured by Miami-based Llorens Pharmaceuticals International Division Inc., were included in the recall.
The FDA listed the reason for the recall as “Foreign object: black particulate matter.” The FDA or the company did not identify the black particulate matter in its enforcement report.
The affected product was sold in 8-ounce amber bottles, with 47 servings per bottle. The recalled bottles are under lot B2025 and have an expiration date of August 2027, according to the FDA listing.
The recall is for products that were distributed to Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, and Puerto Rico.
The recall remains ongoing, according to the FDA's notice. The company initiated the voluntary recall in early May and notified its public or consignee contacts by letter, according to the FDA’s report. Meanwhile, the FDA listed the recall event and classified it on May 19.
Foreign particulate matter in ingestible products can raise quality control and consumer safety concerns because it often indicates contamination during manufacturing, packaging, or filling.
While failed specifications were the leading cause of pharmaceutical recalls, foreign materials in products were the second leading cause of pharmaceutical recalls.
Individuals who have used affected products should monitor for unusual symptoms and consult a health care provider if concerns arise or if the supplements are needed for health conditions.
Adverse reactions can also be reported to the FDA’s MedWatch program.
