Complete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials
Complete Pharmacy and Medical Solutions LLC is recalling 49 vials of Human Chorionic Gonadotropin due to confirmed bacterial 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 according to the rubric.
Plain-English summary
Complete Pharmacy and Medical Solutions LLC is recalling 49 vials of Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection. The product is prescription-only and was distributed nationwide and in Puerto Rico.
The recall was initiated because an outside laboratory confirmed the presence of bacteria in the product after day 14. The affected lot is # 22016 with an expiration date of 1/30/2017.
Consumers and healthcare providers should stop using the recalled product immediately. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Manufacturer
- Complete Pharmacy and Medical Solutions LLC
- Category
- Drug — Injectable
- Affected units
- 49
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 # 22016
- Exp 1/30/2017
Distribution
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