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.
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 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.
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