FDA Recalls Potentially Non-Sterile Supplements
Tri-Coast Pharmacy is recalling various lots of products with sterility assurance concerns.
The FDA recently announced the recall of all Tri-Coast Pharmacy Inc sterile products manufactured between May and November of this year. The voluntary recall is the result of FDA concerns regarding the product’s lack of sterility assurance.
Using a sterile drug or product that actually has microbial contamination could result in serious, life-threatening infections, according to a press release from the FDA.
Thus far, no products have been deemed non-sterile, but there is a concern that they were manufactured in an environment that could have potentially caused contamination. There have also been no adverse events reported to Tri-Coast Pharmacy.
The affected products are used for a variety of purposes, and include many different vitamin supplements, such as an amino energy cocktail, ascorbic acid, B-complex compound, and different vitamin cocktails. There are nearly 100 recalled products, many with multiple lots affected.
All recalled products will display the Tri-Coast Pharmacy Inc label, as well as their logo, the drug name, recalled lot number, and the proper expiration date. Any customers who are unsure about the status of their product should call the pharmacy to determine their next steps, according to the FDA.
The main concern of the company is to make sure patients are safe, and they recommend that the affected products should be quarantined and discontinued immediately, according to a press release. Consumers should make contact with the company to facilitate a return of any affected products.
If patients taking these products experience any adverse events that could be associated with using the products, they should contact their healthcare provider immediately. All adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program.
The FDA also said that providers that have dispensed any of these products should contact the patient it was administered to, and ensure they are aware of the recall.
The recall is being conducted in cooperation with the FDA, and Tri-Coast Pharmacy is taking this action out of an abundance of caution, the press release concluded.