SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 128 syringes of Hydromorphone HCL 1 mg/mL 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 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
SCA Pharmaceuticals, LLC is recalling 128 single-dose syringes of HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride. The specific product is the 25 mL fill in 30 mL syringe with NDC 70004-0303-17. The recall is being conducted because of a lack of assurance of sterility.
The affected lot number is 20170808@52, with a beyond-use date of 11/06/2017. The product was distributed nationwide in the United States.
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 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Affected units
- 128
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)
- Lot: 20170808@52 BUD: 11/06/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC 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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