SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 7,890 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
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 a medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 7,890 syringes of Phenylephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride. The recall is due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit.
The affected product is distributed to hospitals nationwide. Specific lot numbers and expiration dates are listed in the recall documentation. The product is a prescription-only medication intended for single-dose use.
Hospitals and healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 7,890
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 (13)
- Lot # 1220023039
- BUD 1/21/2021
- 1220023080
- BUD 1/24/2021
- 1220023374
- BUD 2/3/2021
- 1220023375
- BUD 2/2/2021
- 1220023490
- BUD 2/7/2021
- 1220023554
- BUD 2/8/2021 & 1220023837
- BUD 2/14/2021.
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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