Recall record at a glance
| Official record | D-0922-2018 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | La Vita Compounding Pharmacy, LLC |
| Report date | Jul 25, 2018 |
| Recall initiation date | Jun 25, 2018 |
| Quantity | 17,610 mL total dispensed in 10 mL and 30 mL vials |
| Location | San Diego, CA, United States |
Official 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
Why the product 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.
Distribution information
Product was distributed to patients via patient specific prescription only in CA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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