The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0295-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Slim Shot Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 127 vials of Slim Shot 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 and involves a lack of assurance of sterility in a compounded drug, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Tri-Coast Pharmacy is recalling 127 vials of Slim Shot, a compounded sterile product containing Methionine, Inositol, Choline Chloride, Methylcobalamin, and Pyridoxine HCL. The recall covers all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes with expiration dates include 06292016A (12/26/2016), 08102016C (01/31/2017), and 10262016C (02/28/2017).

The recall was initiated due to a lack of assurance of sterility. The product was distributed nationwide. The FDA has classified this recall as Class II.

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

The recalled product

Product
Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
127

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 (2)

  • 08102016C (01/31/2017)
  • 10262016C (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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