Guardian Pharmacy Recalls Ropivacaine HCl Due to Sterility Concerns
Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL 750 mL ON-Q Pumps due to a lack of sterility assurance. The affected product was 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 significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL 750 mL, packaged in an ON-Q Pump. The recall is being conducted due to a lack of sterility assurance in the compounded medication. The product is prescription-only and was distributed in Texas.
The specific lot affected is 59103:42, with a use-by date of 05/25/2018. The quantity involved is three 750-ml ON-Q Pumps. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for further instructions. The recall is limited to the specific lot and distribution area identified in the source text.
The recalled product
- Product
- Ropivacaine HCl 2 mg/mL 750 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 Medication
- 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 (1)
- Lot: 59103:42 Use By: 05/25/2018
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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