Why it was recalled
CGMP deviations: Lack of potency testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 40568 Use By Date: 01/30/2021
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0234-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2020
- FDA report date
- Jan 27, 2021
- Quantity
- 1182 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Complete Pharmacy and Medical Solutions, LLC.
Original FDA data
Every field from FDA enforcement report D-0234-2021, exactly as published.
Show all FDA fields
- City
- Miami Lakes
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 87076
- Address
- 5829 Nw 158th St
- Code information
- Lot #: 40568 Use By Date: 01/30/2021
- Postal code
- 33014-6721
- Report date
- Jan 27, 2021
- Product type
- Drugs
- Recall number
- D-0234-2021
- Classification
- Class II
- Recalling firm
- Complete Pharmacy and Medical Solutions, LLC.
- Product quantity
- 1182 vials
- Termination date
- Sep 28, 2022
- Reason for recall
- CGMP deviations: Lack of potency testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 20, 2020
- Initial firm notification
- Center classification date
- Jan 19, 2021