Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Human Chorionic Gonadotropin 5
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP deviations: Lack of potency testing.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Drug: Mannitol
- Recalling firm
- Complete Pharmacy and Medical Solutions, LLC.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0236-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mannitol recalls
See all
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class III · Low risk
NETSPOT (kit for the preparation of Ga 68 dotatate injection)
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Other recalls by Complete Pharmacy and Medical Solutions, LLC.
All 2020 recalls
Class II · Moderate risk
Human Chorionic Gonadotropin 1
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
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