CLASS II Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Cyanocobalamin Injection, all strengths recalled by FVS Holdings
FVS Holdings is recalling Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin, distributed nationwide in the US. The recall was initiated on 10 Apr 2013 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-355-2013
- FDA event ID
- 64879
- Recalling firm
- FVS Holdings, Henderson, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Apr 2013
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Apr 2013 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +36 days |
| 22 May 2013 | Published in enforcement report | +6 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: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Which lots are affected?
Lot #: a) Cyanocobalamin 1000mcg: 20130214-C, Exp 5/14/2013; 20130220-B, Exp 5/20/2013; 20130226-D, Exp 5/26/2013; 20130226-E, Exp 5/26/2013; 20130226-L, Exp 5/26/2013; 20130125-E, Exp 4/25/2013; 20130125-D, Exp 4/25/2013; 20130125-C, Exp 4/25/2013; 20130125-F, Exp 4/25/2013; 20130211-M, Exp 5/11/2013; 20130214-B, Exp 5/14/2013; 20130221-D, Exp 5/21/2013; 20130225-K, Exp 5/25/2013; 20130214-B, Exp 5/14/2013; 20130226-C, Exp 5/26/2013; 20130226-I, Exp 5/26/2013; 20130225-M, Exp 5/25/2013; 20130225-N, Exp 5/25/2013; 20130225-J, Exp 5/25/2013; 20130225-C, Exp 5/25/2013; 20130204-G, Exp 5/4/2013; 20130204-F, Exp 5/4/2013; b) Cyanocobalamin 1000mcg 30ml: 20130325-D, Exp 6/25/2013; 20130325-C, Exp 6/25/2013; 20130326-E, Exp 6/26/2013; 20130326-I, Exp 6/26/2013; 20130329-L, Exp 6/29/2013; 20130329-M, Exp 6/29/2013; 20130306-Q, Exp 6/6/2013; 20130308-K, Exp 6/8/2013; 20130401-O, Exp 7/1/2013; 20130401-M, Exp 7/1/2013; 20130402-C, Exp 7/2/2013; 20130402-B, Exp 7/2/2013; 20130329-K, Exp 6/29/2013; 20130308-L, Exp 6/8/2013; 20130401-N, Exp 7/1/2013; 20130402-H, Exp 7/2/2013; 20130402-D, Exp 7/2/2013; 20130402-A, Exp 7/2/2013; 20130403-A, Exp 7/3/2013; 20130318-P, Exp 6/18/2013; 20130318-O, Exp 6/18/2013; 20130318-Q, Exp 6/18/2013; 20130319-B, Exp 6/19/2013; 20130226-B, Exp 5/26/2013; 20130318-A, Exp 6/18/2013
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
77 other products · FDA event 64879This product is part of a recall event; the main page for the event is Medroxyprogesterone Acetate Injection, all strengths recalled.
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|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Bicarbonate Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |
| Drug | CLASS II | Progesterone Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |
| Drug | CLASS II | Polidocanol Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |
| Drug | CLASS II | Hydrogen Peroxide Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |
Other Cyanocobalamin recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial recalled | Zydus Pharmaceuticals | Particulate Matter | TN |
| Drug | CLASS II | Cyanocobalamin 2 mg/mL, Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |