The Recall Desk
SevereFDA (Drugs)·D-0744-2016·Announced 2016-03-16

Hartley Medical Center Pharmacy Recalls Morphine and Bupivacaine Syringes

Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL 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 under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable medications.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, 40 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. No foreign distribution occurred. The specific product code is identified by a Beyond Use Date (BUD) of 5/3/2016.

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

The recalled product

Product
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
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 →