Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Lack of Potency Testing
Complete Pharmacy and Medical Solutions is recalling 2,400 vials of Human Chorionic Gonadotropin 1,250 IU due to a lack of potency testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a CGMP deviation (lack of potency testing) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Complete Pharmacy and Medical Solutions, LLC. is recalling 2,400 vials of Human Chorionic Gonadotropin 1,250 IU. The product is a lyophilized, unpreserved injection containing Mannitol 9% and Sodium Phosphate 2% in water for injection. The specific lot number is 40548, with a use-by date of 01/30/2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically a lack of potency testing. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
- Manufacturer
- Complete Pharmacy and Medical Solutions, LLC.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,400
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 (3)
- Lot #: 40548
- Use By Date
- 01/30/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Complete Pharmacy and Medical Solutions, LLC. 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 4 products in this recall →Related recalls
Same manufacturer · Complete Pharmacy and Medical Solutions, LLC.
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FDA (Drugs) · 2021-01-27
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- ModerateComplete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Failures
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- CriticalComplete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials
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