The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0275-2017·Announced 2017-01-11

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.

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 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…
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
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.

See all 80 products in this recall →

Related recalls

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · lack of sterility

See all →

Similar recalls