Sermorelin Acetate and Ipamorelin Vials Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 9mg/Ipamorelin 9mg lyophilized vials (Lot 08102021:22) distributed in the United States due to 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: This recall is classified as FDA Class II. The hazard—lack of sterility assurance in an injectable pharmaceutical—presents significant risk of serious infection or harm to patients. While no illnesses have been reported in the source text, injectable products with sterility failures represent a category of risk that merits Severe classification under Class II criteria.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247, is recalling Sermorelin Acetate 9mg/Ipamorelin 9mg lyophilized vials in 9mg/9mg strength. The recall applies to Lot 08102021:22 with a BUD (Beyond Use Date) of 11/30/2021. The product is a prescription medication supplied in 3-vial packages.
The recall was initiated due to lack of assurance of sterility. This injectable pharmaceutical product requires sterile conditions to ensure patient safety, and the inability to guarantee sterility poses a potential health risk to patients who receive injections from these vials.
The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received injections from this lot should consult their healthcare provider for guidance.
The recalled product
- Product
- SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 3
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 (1)
- Lot: 08102021:22 BUD: 11/30/2021
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding 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.
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