Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Lack of Potency Testing
Complete Pharmacy and Medical Solutions is recalling 1,144 vials of Human Chorionic Gonadotropin 5,000 IU 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. According to 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 1,144 vials of Human Chorionic Gonadotropin 5,000 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 40570, 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. The FDA has classified this recall as Class II, indicating a situation where 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 should stop using the recalled product and contact the recalling firm, Complete Pharmacy and Medical Solutions, LLC., at 305-397-2035 for further instructions.
The recalled product
- Product
- HUMAN CHORIONIC GONADOTROPIN 5,000 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
- 1,144
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 #: 40570 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.
See all →- SevereComplete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Deviations
FDA (Drugs) · 2021-01-27
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- ModerateComplete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Failures
FDA (Drugs) · 2021-01-27
- CriticalComplete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials
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