Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes
Hartley Medical Center Pharmacy is recalling specific syringes of Hydromorphone and Bupivacaine 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, and the hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of infection or injury.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling 40 ml syringes containing Hydromorphone HCL 25 mg/ml and Bupivacaine HCL 4 mg/ml. The recall is being conducted because there is a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed nationwide. No foreign distribution is reported. The specific product code is identified by a Best Use Date (BUD) of 5/3/2016.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Pharmacy Compounded
- 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.
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