CLASS II Drug recall · Reported 27 Jan 2021 · FDA Enforcement Report
Human Chorionic Gonadotropin 11,000 IU per vial Aso recalled
Complete Pharmacy and Medical Solutions is recalling Human Chorionic Gonadotropin 11,000 IU per vial Aso contains Mannitol 9%, Sodium, distributed nationwide in the US. The recall was initiated on 20 Nov 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0234-2021
- FDA event ID
- 87076
- Recalling firm
- Complete Pharmacy and Medical Solutions, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2020
- FDA classified
- 19 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Nov 2020 | Recall initiated by company | |
| 19 Jan 2021 | Classified by FDA | +60 days |
| 27 Jan 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: Lack of potency testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP deviations: Lack of potency testing.
Which lots are affected?
Lot #: 40568 Use By Date: 01/30/2021
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 87076This product is part of a recall event; the main page for the event is Human Chorionic Gonadotropin 1,250 IU per vial Aso contains recalled.