Talon Compounding Pharmacy Recalls Human Chorionic Gonadotropin Injection Due to Sterility Concerns
Talon Compounding Pharmacy is recalling 6,500 vials of Human Chorionic Gonadotropin Injection nationwide due to a 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a risk of harm even without reported illnesses.
Plain-English summary
Talon Compounding Pharmacy, located in San Antonio, Texas, is recalling 6,500 vials of Human Chorionic Gonadotropin Injection. The affected products are available in various strengths, including 2,500 iu, 3,500 iu, 5,000 iu, 6,000 iu, 7,500 iu, 11,000 iu, 15,000 iu, and 20,000 iu, with some formulations containing B12. The injections are packaged in 10 mL sterile, depyrogenated vials and are prescription-only.
The recall was initiated due to a lack of assurance of sterility. The affected products were distributed nationwide. The source text does not specify the exact number of illnesses or injuries associated with this recall.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider for further instructions. The recall number is D-1462-2016.
The recalled product
- Product
- Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile…
- Manufacturer
- Talon Compounding Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 6,500
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by 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.
See all 2 products in this recall →Related recalls
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