Sermorelin/GHRP-6 Injection Recalled for Non-Sterility and Microbial Contamination
Town and Country Compounding and Consultation Services is recalling Sermorelin/GHRP-6 Injection due to non-sterility and Bacillus circulans contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Town and Country Compounding and Consultation Services is recalling 12 vials of Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial. The recall is due to non-sterility, with microbial contamination identified as Bacillus circulans.
The affected product is identified by lot #07172016@1 with an expiration date of 1/13/2017. The product was distributed in Massachusetts, New York, New Jersey, Florida, and Canada.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
- Category
- Drug — Compounded Injectable
- Affected units
- 12
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)
- lot #07172016@1
- exp 1/13/2017
Distribution
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