QuVa Pharma Recalls Phenylephrine Syringes Due to Label Error
QuVa Pharma recalls 20 cases of Phenylephrine syringes in CA due to incorrect strength labeling on the overwrap. Check lot numbers.
Stop using this now
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Contact the company
What happened, in plain English
QuVa Pharma, Inc. is recalling PHENYLephrine 1 mg/10 mL syringes because some units have an incorrectly labeled light protective overwrap showing a strength of .4 mg/10 mL instead of the correct 1 mg/10 mL. The recall affects 20 cases distributed in California. The product code is 75901-1205-35 and the lot number is 14312-0, which expires on 4/15/2016. Read more at govinfonow.com/recall/43023-quva-pharma-recalls-phenylephrine-syringes-due-to-label-error.
Source Summary by GovInfoNow · govinfonow.com/recall/43023-quva-pharma-recalls-phenylephrine-syringes-due-to-label-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-1066-2016
Cite this page
“QuVa Pharma Recalls Phenylephrine Syringes Due to Label Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43023-quva-pharma-recalls-phenylephrine-syringes-due-to-label-error. Based on FDA recall #D-1066-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1066-2016%22&limit=1).
Why it’s dangerous
The labeling error declares a strength of .4 mg/10 mL when the actual content is 1 mg/10 mL. This discrepancy can lead to the administration of a higher dose than intended, posing a serious risk to patient safety.
Who’s affected
Healthcare providers or patients in California who purchased this specific Rx-only infusion therapy product. The risk applies to anyone using the affected syringes with the incorrect label.
How to tell if you have this one
Look for PHENYLephrine 1 mg/10 mL in 0.9% Sodium Chloride, 10 mL syringes packaged in cases of 24. Check the light protective overwrap for the incorrect label '.4 mg/10 mL (40 mcg/ml)' and verify the lot number is 14312-0 with an expiration date of 4/15/2016.
- Brand
QuVa Pharma- Category
Drug
What to do — step by step
Check Product Labels
Verify if your syringes have the incorrect overwrap label showing .4 mg/10 mL and match the lot number 14312-0.
Contact Manufacturer
The recall record does not specify a remedy or return process, so you must contact QuVa Pharma directly for further instructions.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other QuVa Pharma recalls
Latest drug recalls
Keep exploring
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-1066-2016 (March 30, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1066-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.