Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Failures
Complete Pharmacy and Medical Solutions is recalling 2,418 vials of Human Chorionic Gonadotropin because the product lacked required 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, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Complete Pharmacy and Medical Solutions, LLC. is recalling 2,418 vials of Human Chorionic Gonadotropin 6,000 IU per vial. The recalled product is a lyophilized, unpreserved injection containing Mannitol 9% and Sodium Phosphate 2% in water for injection. The specific lot affected is Lot# 40604, which has 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 product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HUMAN CHORIONIC GONADOTROPIN 6,000 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
- Hazard
- Affected units
- 2,418
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# 40604 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 Lack of Potency Testing
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- CriticalComplete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials
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