CLASS II Drug recall · Reported 27 Aug 2014 · FDA Enforcement Report
CYTARAbine for Injection USP, lyophiled in glass vials per vial recalled
Ben Venue Laboratories is recalling CYTARAbine for Injection USP, lyophiled in glass vials per vial, distributed nationwide in the US. The recall was initiated on 31 Jul 2014 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-1543-2014
- FDA event ID
- 68800
- Recalling firm
- Ben Venue Laboratories, Bedford, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2014
- FDA classified
- 18 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Jul 2014 | Recall initiated by company | |
| 18 Aug 2014 | Classified by FDA | +18 days |
| 27 Aug 2014 | Published in enforcement report | +9 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: Crimp defects during visual inspection could affect container closure integrity.
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
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Which lots are affected?
Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
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.
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|---|---|---|---|---|---|
| Drug | CLASS I | Acetylcysteine Solution, USP, 10% vial recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Leucovorin Calcium Injection USP, single use vials, 10mg/mL recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection, For IV use only recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Midazolam HCl Injection, 5 mg/mL single use vials recalled | Ben Venue Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Octreotide Acetate Injection, 50 mcg/mL recalled | Ben Venue Laboratories | Packaging Defects | Nationwide |
Other Cytarabine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cytarabine 128 MG/ D5W IVPB recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS I | Cytarabine Injection 100 mg/ (20 mg/mL) Single-Dose Vial recalled | Mylan Institutional | Particulate Matter | Nationwide |
| Drug | CLASS II | Cytarabine Injection, 20 mg/mL Single Dose Vial recalled by Hospira | Hospira | Particulate Matter | Nationwide |