Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns
Hartley Medical Center Pharmacy is recalling specific hydromorphone, baclofen, 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling 40 ml syringes containing Hydromorphone HCL 10 mg/ml, Baclofen 460 mcg/ml, and Bupivacaine HCL. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed nationwide. The specific lot identified in the recall has a beyond-use date of May 3, 2016. No foreign distribution is reported.
Consumers and healthcare providers should stop using the affected syringes and contact the pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable Medication
- 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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