The Recall Desk
SevereFDA (Drugs)·D-0323-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Ultra Cocktail #2 Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 123 vials of Ultra Cocktail #2 compounded between May and November 2016 because the agency cannot assure the products are sterile.

What this means for you

Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Tri-Coast Pharmacy is recalling 123 vials of Ultra Cocktail #2, a compounded sterile product containing various vitamins, minerals, and lidocaine. The recall covers 30 mL and 10 mL vials distributed nationwide. The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016.

The recall was initiated due to a lack of assurance of sterility. The specific lot codes affected are 05192016A, 08032016B, 08232016A, and 09292016C. The expiration dates for these lots range from December 31, 2016, to January 31, 2017.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML
Manufacturer
Tri-Coast Pharmacy
Affected units
123

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 (3)

  • 08032016B (12/31/2016)
  • 08232016A (12/31/2016)
  • 09292016C (01/31/2017).

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.

See all 80 products in this recall →