Alvogen Clindamycin Injection Recall: Risk of Contamination
Alvogen recalls 4mL single-dose clindam: Risk of contamination from lack of sterility assurance. Check NDC 47781-463-69 and lot numbers for affected vials.
Stop using this now
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Alvogen is recalling clindamycin injection vials that may not be sterile, which could lead to infections if used. This is a serious hazard for patients receiving the medication. Read more at govinfonow.com/recall/41555-alvogen-clindamycin-injection-recall-risk-of-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/41555-alvogen-clindamycin-injection-recall-risk-of-contamination · Updated October 8, 2026 · FDA enforcement record: FDA #D-0940-2017
Cite this page
“Alvogen Clindamycin Injection Recall: Risk of Contamination.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41555-alvogen-clindamycin-injection-recall-risk-of-contamination. Based on FDA recall #D-0940-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0940-2017%22&limit=1).
Why it’s dangerous
The vials may not be sterile, meaning they could introduce harmful bacteria into the body when injected. This poses a risk of infection or other complications for patients receiving the medication.
Who’s affected
Patients prescribed clindamycin injection by a doctor. Those with the specific vial lot numbers or expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check for the NDC code 47781-463-69 on the vial. Look for lot numbers 68-104-EV (expiring 07/31/18) or 73-155-EV/73-156-EV (expiring 12/31/18).
- Brand
Alvogen- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0939-2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69; Lot: 73-154-EV; Exp. 12/31/17 | 5,100 2 mL vials |
| D-0940-2017 | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69; Lots: 68-104-EV; Exp 07/31/18, 73-155-EV; Exp. 12/31/18, 73-156-EV; Exp.12/31/18 | 72,575 4 mL vials |
| D-0941-2017 | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69; Lots: 68-105-EV; Exp. 07/31/18, 68-106-EV; Exp. 07/31/18, and 73-157-EV; Exp. 12/31/18 | 71,825 6 mL vials |
What to do — step by step
Stop Using Now
Immediately discard the vial if it has the NDC 47781-463-69 and lot numbers 68-104-EV, 73-155-EV, or 73-156-EV.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0940-2017 (June 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0940-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.