Sermorelin Injection Recalled Due to Sterility Assurance Concerns
DCA Pharmacy is recalling 129 vials of Sermorelin 6mg/6mL Lyophilized Powder because an FDA inspection found it was not compounded in an appropriate area, potentially compromising 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 potential sterility failures in injectable compounds are categorized as Severe (Score 4) due to the risk of infection, even without reported hospitalizations in the text.
Plain-English summary
Diabetes Corporation of America dba DCA Pharmacy is recalling 129 vials of Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection. The product is identified by Lot # 101614 with an expiration date of 4/30/2015. The recall was initiated after a recent FDA inspection determined that the product was not being compounded in an area appropriate for lyophilization.
This condition may lead to a lack of sterility assurance for the sterile compound. The affected product was distributed in Kentucky, Ohio, and Tennessee. No specific illnesses or injuries have been reported in the source text.
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 recall is classified as FDA Class II.
The recalled product
- Product
- Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
- Manufacturer
- Diabetes Corporation of America dba DCA Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 129
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 #: 101614
- Exp 4/30/2015
Distribution
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