Tri-Coast Pharmacy Recalls Ultra Slim Shot Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 874 vials of Ultra Slim Shot compounded between May and November 2016 because the products lack assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Tri-Coast Pharmacy is recalling 874 vials of Ultra Slim Shot, a compounded sterile product containing Methionine, Inositol, Choline Chloride, Methylcobalamin, Carnitine, Pyridoxine HCL, and Lidocaine HCL. The recall covers all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016.
The recall was initiated due to a lack of assurance of sterility. The specific lot codes and expiration dates included in the recall are 06232016C (12/20/2016), 07272016B (12/31/2016), 08232016B (01/31/2017), 10262016D (02/28/2017), and 09202016C (03/19/2016).
The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 874
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 07272016B (12/31/2016)
- 08232016B (01/31/2017)
- 10262016D (02/28/2017)
- 09202016C (03/19/2016).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by Tri-Coast Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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