Guardian Pharmacy Recalls Ropivacaine HCl ON-Q Pumps for Sterility Concerns
Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL ON-Q Pumps due to a lack of sterility assurance. The products were distributed in Texas.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in a compounded drug, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL, packaged in ON-Q Pumps, due to a lack of sterility assurance. The recalled product is a prescription-only medication compounded by Guardian Pharmacy Services, located in Dallas, Texas.
The recall involves two specific lots: Lot 59086:42 with a use-by date of 05/24/2018, and Lot 59163:42 with a use-by date of 05/30/2018. These products were distributed in Texas.
Patients who have received this medication should contact their healthcare provider for guidance on next steps. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Compounded Prescription
- Hazard
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)
- Lots: 59086:42 Use By: 05/24/2018
- 59163:42 Use By: 05/30/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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