SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Hydromorphone injection syringes because they may leak and lack 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from a lack of sterility assurance in an injectable drug.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling specific lots of Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringes. The product is identified by NDC# 70004-0302-05 and Lot 20170508@75, with a beyond-use date of 8/6/2017.
The recall was initiated due to a lack of assurance of sterility and the potential for the product to leak. This defect could compromise the safety and integrity of the medication.
The affected product was distributed nationwide. Healthcare providers and patients should discontinue use of the recalled product and contact SCA Pharmaceuticals or their local FDA office for further instructions.
The recalled product
- Product
- Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
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: 20170508@75 BUD: 8/6/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by SCA Pharmaceuticals 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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