D-0236-2021 Class II Terminated
FDA drug recall D-0236-2021 was initiated by Complete Pharmacy And Medical Solutions, LLC. on Nov 20, 2020 and is designated Class II. Reason for recall: CGMP deviations: Lack of potency testing. The recall status is terminated (terminated Sep 28, 2022). Affected quantity: 1144 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 27, 2021
- Initiation Date
- Nov 20, 2020
- Termination Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1144 vials
Product Description
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
Reason for Recall
CGMP deviations: Lack of potency testing.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #: 40570 Use By Date 01/30/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0236-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026