QuVa Pharma Recalls Phenylephrine Syringes Due to Labeling Error
QuVa Pharma is recalling 20 cases of Phenylephrine syringes because some units have incorrect strength labels on the protective overwrap.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 according to the rubric, despite the hazard being a labeling error.
Plain-English summary
QuVa Pharma, Inc. is recalling 20 cases of Phenylephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringes. The product is packaged in cases of 24 syringes and is prescription-only. The specific lot number is 14312-0, with an expiration date of 4/15/2016.
The recall was initiated due to a labeling error on the declared strength. While the syringes and cases have the correct labels, some units are incorrectly labeled as .4 mg/10 mL (40 mcg/mL) on the light protective overwrap of each syringe. The affected product was distributed in California.
Healthcare providers and patients should stop using the affected product and contact QuVa Pharma, Inc. for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 14312-0
- Exp 4/15/2016
Distribution
Distributed in 1 state:
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