CLASS II Drug recall · Reported 13 Nov 2019 · FDA Enforcement Report
S-vit B Complex (1/3/5/6/12A) Mdv Inj 100/2/2/100/1MG/ML glass vial recalled
First Royal Care Co. LLC is recalling S-vit B Complex (1/3/5/6/12A) Mdv Inj 100/2/2/100/1MG/ML glass vial, distributed nationwide in the US. The recall was initiated on 12 Aug 2019 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-0255-2020
- FDA event ID
- 83669
- Recalling firm
- First Royal Care Co. LLC, Mesa, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Aug 2019
- FDA classified
- 5 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Aug 2019 | Recall initiated by company | |
| 5 Nov 2019 | Classified by FDA | +85 days |
| 13 Nov 2019 | Published in enforcement report | +8 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 Assurance of Sterility
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx
Where it was distributed
Nationwide in the USA
Questions about this recall
Is S-vit B Complex (1/3/5/6/12A) Mdv Inj 100/2/2/100/1MG/ML glass vial recalled?
Yes. First Royal Care Co. LLC recalled S-vit B Complex (1/3/5/6/12A) Mdv Inj 100/2/2/100/1MG/ML glass vial on 12 Aug 2019. The recall is Class II and its status is Terminated. Recall number D-0255-2020.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: S07232019DH@08 Exp 10/23/19
Where was it sold?
Nationwide in the USA
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 First Royal Care Co. LLC
All 140| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Acetylcysteine 2% Opth Soln recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Mic/b12a/b6 15/50/100 5mg/50mg/ML Mdv recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |