SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
SCA Pharmaceuticals is recalling 1,056 units of HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL). The affected products are 30 mL Plungerless Single Dose Syringes and 30 mL Single Dose Syringes, both marked as Rx Only. The recall is due to a lack of assurance of sterility, which may result from a defective syringe cap that creates a non-integral unit.
The affected lots include Lot # 1220022964 (BUD 1/19/2021), Lot # 1220023280 (BUD 2/1/2021), Lot # 1220023623 (BUD 2/10/2021), and Lot # 1220023347 (BUD 2/17/2021). The product was distributed to hospitals nationwide.
Hospitals and healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions. Patients should consult their healthcare provider if they have questions regarding the use of this medication.
The recalled product
- Product
- HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,056
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 (6)
- a) Lot # 1220022964
- BUD 1/19/2021
- 1220023280
- BUD 2/1/2021 & 1220023623
- BUD 2/10/2021. b) Lot # 1220023347
- BUD 2/17/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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