SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 23,029 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 the hazard involves a lack of assurance of sterility in a parenteral medication, which poses a significant risk of serious injury or infection.
Plain-English summary
SCA Pharmaceuticals is recalling 23,029 single-dose syringes of Phenylephrine HCl 1000 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 was distributed to hospitals nationwide. The recall covers specific lots with expiration dates ranging from January 14, 2021, to February 11, 2021.
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
- PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 23,029
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 (20)
- Lot # 1220022957
- BUD 1/20/2021
- 1220022993
- BUD 1/21/2021
- 1220023020
- BUD 1/14/2021
- 1220023037
- BUD 1/19/2021
- 1220023038
- 1220023074
- 1/24/2021
- 1220023103
- BUD 1/24/2021
- 1220023160
- BUD 1/26/2021
- 1220023180
- BUD 1/27/2021
- 1220023183
- 1220023216
- BUD 1/28/2021
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.
See all 32 products in this recall →Related recalls
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