The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0292-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 441 vials of Sermorelin Forte Plus 18 mg because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.

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 are assigned a severity score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised, posing a risk of serious injury.

Plain-English summary

Tri-Coast Pharmacy is recalling 441 vials of Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg) due to a lack of assurance of sterility. The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016.

The recall is classified as Class II by the FDA. Specific lot codes identified in the recall include 05252016C (expiration date 11/21/2016), 07252016B (expiration date 01/21/2017), and 09192016B (expiration date 03/18/2016). The source text does not specify the geographic distribution of the affected units.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement. The source text does not report any illnesses or injuries associated with the use of these products.

The recalled product

Product
Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
441

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)

  • 07252016B (01/21/2017)
  • 09192016B (03/18/2016).

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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