CLASS II Drug recall · Reported 22 Dec 2021 · FDA Enforcement Report
B-Complex, injection vials recalled by Valgene Incorporated
Valgene Incorporated is recalling B-Complex, injection vials, distributed in Maryland. The recall was initiated on 3 Dec 2021 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-0284-2022
- FDA event ID
- 89209
- Recalling firm
- Valgene Incorporated, Annapolis, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2021
- FDA classified
- 15 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Dec 2021 | Recall initiated by company | |
| 15 Dec 2021 | Classified by FDA | +12 days |
| 22 Dec 2021 | Published in enforcement report | +7 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
Product as listed by the FDA
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Where it was distributed
Maryland Only
Questions about this recall
Is B-Complex, injection vials recalled?
Yes. Valgene Incorporated recalled B-Complex, injection vials on 3 Dec 2021. The recall is Class II and its status is Terminated. Recall number D-0284-2022.
Why was it recalled?
Lack of Processing Controls
Which lots are affected?
Lot# 190036, BUD 12/27/2021
Where was it sold?
Maryland Only
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 Valgene Incorporated
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin 12mg/ml injection vials recalled by Valgene Incorporated | Valgene Incorporated | Other | MD |