Why it was recalled
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Product description
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Lot numbers, UPCs & expiration codes
Lot #: 140089@1, Exp 08/06/2018; 141968@6, Exp 09/03/2018; 143381@2, Exp 09/24/2018; 145265@13, Exp 10/22/2018; 146479@6, Exp 11/12/2018
Where it was sold
Product was distributed to patients via patient specific prescription only in CA.
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-0922-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 25, 2018
- FDA report date
- Jul 25, 2018
- Quantity
- 17,610 mL total dispensed in 10 mL and 30 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- La Vita Compounding Pharmacy, LLC
Original FDA data
Every field from FDA enforcement report D-0922-2018, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80416
- Address
- 3978 Sorrento Valley Blvd Ste 300
- Code information
- Lot #: 140089@1, Exp 08/06/2018; 141968@6, Exp 09/03/2018; 143381@2, Exp 09/24/2018; 145265@13, Exp 10/22/2018; 146479@6, Exp 11/12/2018
- Postal code
- 92121-1436
- Report date
- Jul 25, 2018
- Product type
- Drugs
- Recall number
- D-0922-2018
- Classification
- Class II
- Recalling firm
- La Vita Compounding Pharmacy, LLC
- Product quantity
- 17,610 mL total dispensed in 10 mL and 30 mL vials
- Termination date
- Jan 18, 2019
- Reason for recall
- Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
- Distribution pattern
- Product was distributed to patients via patient specific prescription only in CA.
- Recall initiation date
- Jun 25, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2018