Sermorelin Acetate/Ipamorelin Vials Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington, D.C., and Puerto Rico.
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 is an FDA Class II recall. Lack of assurance of sterility in an injectable compounded pharmaceutical presents a significant risk of serious infection and potential hospitalization. The agency's classification alone warrants a minimum score of 4 per the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247, is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials (15MG/15MG per vial, prescription-only) due to lack of assurance of sterility. This is an FDA Class II recall.
The affected product is lot 07062021:98 with a beyond-use date (BUD) of 11/30/2021, distributed in packages of 6 vials across the United States, including Washington, D.C. and Puerto Rico.
Patients and healthcare providers who have received this product should stop use and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacement product. Persons who believe they have experienced an adverse reaction should contact the FDA's MedWatch program or local poison control center.
The recalled product
- Product
- SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Pharmaceutical
- Affected units
- 6
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: 07062021:98 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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