Why it was recalled
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Product description
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Lot numbers, UPCs & expiration codes
Lot # 22016, Exp 1/30/2017
Where it was sold
Nationwide and Puerto Rico
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-0918-2017
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Apr 2, 2016
- FDA report date
- Jun 21, 2017
- Quantity
- 49 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Complete Pharmacy and Medical Solutions LLC
Original FDA data
Every field from FDA enforcement report D-0918-2017, exactly as published.
Show all FDA fields
- City
- Miami Lakes
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 76681
- Address
- 5829 NW 158th St
- Code information
- Lot # 22016, Exp 1/30/2017
- Postal code
- 33014-6721
- Report date
- Jun 21, 2017
- Product type
- Drugs
- Recall number
- D-0918-2017
- Classification
- Class I
- Recalling firm
- Complete Pharmacy and Medical Solutions LLC
- Product quantity
- 49 vials
- Reason for recall
- Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 2, 2016
- Initial firm notification
- Center classification date
- Jun 13, 2017