QuVa Pharma Recalls R.E.C.K. Syringes Due to Particulate Matter
QuVa Pharma is recalling 17,050 syringes of R.E.C.K. solution because they may contain particulate matter. The product was distributed nationwide in the US.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural failure.
Plain-English summary
QuVa Pharma, Inc. is recalling 17,050 syringes of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution. The recall is due to the presence of particulate matter in the product. The affected product is a 50 mL solution in a 60 mL syringe, compounded by QuVa in Bloombury, NJ, with NDC 70092143350.
The recalled lots were distributed nationwide in the US. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from April 26, 2020, to June 3, 2020.
Healthcare providers and patients should stop using the affected syringes and contact QuVa Pharma for further instructions or a refund.
The recalled product
- Product
- R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 17,050
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 (20)
- Lots: 30008721
- Exp. 4/26/2020
- 30008198
- 30008554
- Exp. 4/29/2020
- 30008861
- Exp. 4/30/2020
- 30008859
- Exp. 5/5/2020
- 30008949
- Exp. 5/10/2020
- 30009073
- Exp. 5/14/2020
- 30009074
- Exp. 30009138
- Exp. 5/17/2020
- 30009139
- 30009227
- Exp. 5/19/2020
- 30009228
Distribution
Distributed nationwide across the United States.
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