The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0265-2017·Announced 2017-01-11

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

Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2 nationwide 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 and involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2, a compounded sterile product containing various vitamins and minerals. The recall was initiated because of a lack of assurance of sterility in the product.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide. Specific lot codes and expiration dates are listed in the official recall documentation.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by…
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
132

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 (12)

  • if known): 05252016D (05/28/2016)
  • 05202016A (05/23/2016)
  • 05182016C (05/21/2016)
  • 05092016C (05/12/2016)
  • 05022016C (05/05/2016)
  • 06132016D (06/16/2016)
  • 06072016A (06/10/2016)
  • 06062016A (06/09/2016)
  • 07282106E (07/31/2016)
  • 07252016G (07/28/2016)
  • 09122016A (09/15/2016)
  • 09192016B (09/22/2016)

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.

See all 80 products in this recall →

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