CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report
Methyl Folate CA+ 1mg/ml Injection w/Pres recalled
La Vita Compounding Pharmacy is recalling Methyl Folate CA+ 1mg/ml Injection w/Pres, distributed in California. The recall was initiated on 25 Jun 2018 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-0922-2018
- FDA event ID
- 80416
- Recalling firm
- La Vita Compounding Pharmacy, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2018
- FDA classified
- 13 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Jun 2018 | Recall initiated by company | |
| 13 Jul 2018 | Classified by FDA | +18 days |
| 25 Jul 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to patients via patient specific prescription only in CA.
Questions about this recall
Is Methyl Folate CA+ 1mg/ml Injection w/Pres recalled?
Yes. La Vita Compounding Pharmacy recalled Methyl Folate CA+ 1mg/ml Injection w/Pres on 25 Jun 2018. The recall is Class II and its status is Terminated. Recall number D-0922-2018.
Why was it recalled?
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Which lots are affected?
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 was it sold?
Product was distributed to patients via patient specific prescription only in CA.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from La Vita Compounding Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glutathione 200mg/mL Injection w/Pres recalled | La Vita Compounding Pharmacy | Sterility | CA |
| Drug | CLASS II | Methylcobalamin 1mg/mL Injection w/Pres recalled | La Vita Compounding Pharmacy | Sterility | CA |