The Recall Desk
SevereFDA (Drugs)·D-0749-2016·Announced 2016-03-16

Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

Hartley Medical Center Pharmacy is recalling specific hydromorphone and bupivacaine syringes due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score according to the rubric for drug recalls.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 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 lot identified in the recall has a best-use date of May 3, 2016. No foreign distribution is reported.

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

The recalled product

Product
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
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 →