The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1064-2018·Announced 2018-08-15

Guardian Pharmacy Recalls Ropivacaine HCl Due to Sterility Concerns

Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL in 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. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in a medical device/drug combination warrants a 'Severe' rating (Score 4), particularly given the potential for serious injury from non-sterile administration.

Plain-English summary

Guardian Pharmacy Services is recalling 20 units of Ropivacaine HCl 2 mg/mL 400 mL, packaged in ON-Q Pumps, due to a lack of sterility assurance. The product is compounded by Guardian Pharmacy Services, located in Dallas, Texas.

The recall affects specific lots with the following use-by dates: Lot 59088:42 (Use By 05/24/2018) and Lot 59159:42 (Use By 05/30/2018). The distribution pattern for this recall is limited to Texas.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Ropivacaine HCl 2 mg/mL 400 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 Injectable
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: 59088:42 Use By: 05/24/2018
  • 59159:42 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.

See all 23 products in this recall →

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