Recall events
/
Event 80416
Event summary
Timeline bucket June 25, 2018
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording La Vita Compounding Pharmacy, LLC
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
3 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 3
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
D-0921-2018
Recall number D-0921-2018
Initiated June 25, 2018
Classification Class II
Status Terminated
Quantity 19,040 mL total dispensed in 10 mL and 30 mL vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
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.
Code information Lot #s: 139140@3, Exp 07/23/2018; 141106@1, Exp 08/21/2018; 142919@13, Exp 09/17/2018; 143291@6, Exp 09/23/2018; 145701@3, Exp 10/29/2018; 146932@3, Exp 11/19/2018
Distribution pattern Product was distributed to patients via patient specific prescription only in CA.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4193]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
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
D-0922-2018
Recall number D-0922-2018
Initiated June 25, 2018
Classification Class II
Status Terminated
Quantity 17,610 mL total dispensed in 10 mL and 30 mL vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
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.
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
Distribution pattern Product was distributed to patients via patient specific prescription only in CA.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[1960]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
D-0923-2018
Recall number D-0923-2018
Initiated June 25, 2018
Classification Class II
Status Terminated
Quantity 191 vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
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.
Code information Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018
Distribution pattern Product was distributed to patients via patient specific prescription only in CA.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[1948]
FDA event record
· Exact recall-number query on openFDA
