The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0746-2016·Announced 2016-03-16

Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

Hartley Medical Center Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL 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 involves a lack of assurance of sterility, which poses a risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringes. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product is a prescription-only medication distributed nationwide. The specific product code is identified by a Best Use Date (BUD) of 5/3/2016. The recall is classified as Class II by the U.S. Food and Drug Administration.

Consumers and healthcare providers should discontinue use of the affected syringes and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 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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