The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0274-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Myers Cocktail #4 Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 66 vials of Myers Cocktail #4 compounded between May and November 2016 due to a lack of 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the 'lack of assurance of sterility' for an injectable product represents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for significant harm.

Plain-English summary

Tri-Coast Pharmacy is recalling 66 vials of Myers Cocktail #4, a compounded sterile product containing ascorbic acid, magnesium chloride, calcium gluconate, and other vitamins. The recall was initiated because the agency identified a lack of assurance of sterility for these products.

The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The distribution pattern is listed as nationwide. Known lot codes associated with this recall are 06202016DD (expiration date 06/21/2016) and 09132016B (expiration date 02/28/2017).

Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If the product is found, it should be returned to the pharmacy or disposed of according to local regulations. 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.

The recalled product

Product
Myers Cocktail #4 (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/10-mL), (10 ML). Compounded by Tri-Coast…
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
66

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 (1)

  • 09132016B (02/28/2017)

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 →

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