Tri-Coast Pharmacy Recalls Myers Cocktail #5 Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Myers Cocktail #5 vials nationwide because the agency could not ensure the products were 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 source text identifies the hazard as a 'Lack of Assurance of Sterility' for a sterile compounded drug. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the risk of infection from non-sterile injectable products is a significant health hazard that fits the Severe criteria for Class II recalls involving potential serious harm.
Plain-English summary
Tri-Coast Pharmacy is recalling 21 vials of Myers Cocktail #5, a compounded sterile product containing ascorbic acid, magnesium chloride, and various vitamins. The recall covers all sterile products compounded between May 17, 2016, and November 17, 2016, and is distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or disposal. The known lot code for this recall is 07182016A, with an expiration date of December 31, 2016.
The recalled product
- Product
- Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU
- Manufacturer
- Tri-Coast Pharmacy
- Affected units
- 21
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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