Biloxi, MS.-based Coastal Meds, a firm that compounds or mixes the drugs, issued the recall on April 5 without warning the public, FDA said. The agency is urging consumers to not use and dispose of any products made by the company.
The recall was initiated after FDA inspectors found visible particles and poor sterile production practices for products meant for injection use by Coastal Meds, according to an FDA Safety Alert issued on Friday.
Since 2015, Coastal Meds has produced multiple batches of injectable vitamins and weight loss products which have had potency and sterility failures, FDA said, and certain batches of drugs were not properly sampled or tested before passing quality control processes. Some drugs even failed to carry an expiration date or dosage strength and labelling of “Not for resale,” according to the agency.
By injecting a drug product with particulate matter in it, healthcare professionals may risk causing patients “serious and potentially life threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions,” FDA said.
To date, no injuries or adverse reactions have been associated with the current recall, according to the FDA.
Source: USA Today