The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0755-2016·Announced 2016-03-16

Hartley Medical Center Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

Hartley Medical Center Pharmacy is recalling Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/Clonidine HCL 450 mcg/ml syringes due to a lack of assurance of sterility.

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 the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are Severe. While the specific injury reports are not detailed in the snippet, the 'Lack of Assurance of Sterility' for a multi-drug injection containing potent opioids and anesthetics represents a significant risk of serious harm (infection, sepsis), aligning with the Severe criteria for Class II recalls with potential for significant injury.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/Clonidine HCL 450 mcg/ml, 40 ml syringes. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is a prescription-only medication distributed nationwide. The specific lot information provided indicates a Beyond Use Date (BUD) of 5/3/2016. No foreign distribution is reported for this recall.

Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the product.

The recalled product

Product
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Manufacturer
Hartley Medical Center Pharmacy, Incorporated
Category
Drug — Injectable Medication
Hazard
Affected units
1

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)

  • BUD: 5/3/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by Hartley Medical Center Pharmacy, Incorporated 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 30 products in this recall →

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