CLASS II Drug recall · Reported 20 Jun 2012 · FDA Enforcement Report
Octreotide Acetate Injection, 50 mcg/mL 05 mg/mL) single dose vials recalled
Ben Venue Laboratories is recalling Octreotide Acetate Injection, 50 mcg/mL 05 mg/mL) single dose vials, distributed nationwide in the US. The recall was initiated on 1 May 2012 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-1377-2012
- FDA event ID
- 61802
- Recalling firm
- Ben Venue Laboratories, Bedford, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2012
- FDA classified
- 14 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 1 May 2012 | Recall initiated by company | |
| 14 Jun 2012 | Classified by FDA | +44 days |
| 20 Jun 2012 | 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
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Is Octreotide Acetate Injection, 50 mcg/mL 05 mg/mL) single dose vials recalled?
Yes. Ben Venue Laboratories recalled Octreotide Acetate Injection, 50 mcg/mL 05 mg/mL) single dose vials on 1 May 2012. The recall is Class II and its status is Terminated. Recall number D-1377-2012.
Why was it recalled?
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Which lots are affected?
Lot # 2006500, Exp 08/31/12
Where was it sold?
Nationwide and Puerto Rico.
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 Ben Venue Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CYTARAbine for Injection USP, lyophiled in glass vials per vial recalled | Ben Venue Laboratories | Foreign Material | Nationwide |
| 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 |
Other Octreotide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Octreotide Acetate Injection 500 mcg/mL recalled by ViatrisOctreotide Acetate | Viatris | Particulate Matter | Nationwide |