Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns
Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 0.5 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential hospitalization risks or significant injury reports associated with sterility failures.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 0.5 mg/ml, 20 ml syringes. The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is prescription-only and was 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 affected syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Hydromorphone HCL 0.5 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
- 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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