Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Deviations
Complete Pharmacy and Medical Solutions is recalling 1,182 vials of Human Chorionic Gonadotropin because the product lacked required potency testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Complete Pharmacy and Medical Solutions, LLC. is recalling 1,182 vials of Human Chorionic Gonadotropin 11,000 IU per vial. The product is a lyophilized, unpreserved injection containing Mannitol 9% and Sodium Phosphate 2% in water for injection. The specific lot number is 40568, with a use-by date of 01/30/2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the lack of potency testing for the product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers who possess this specific lot of Human Chorionic Gonadotropin should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HUMAN CHORIONIC GONADOTROPIN 11,000 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 Medication
- Hazard
- Affected units
- 1,182
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 #: 40568 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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- CriticalComplete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials
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