SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
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. According to the rubric, an FDA Class II recall involving a drug with a lack of sterility assurance (a significant injury risk) corresponds to a severity score of 4 (Severe).
Plain-English summary
SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL). The product is a prescription-only medication distributed to hospitals nationwide.
The recall was initiated due to a lack of assurance of sterility. There is a potential for a defective syringe cap, which could result in a non-integral unit. The affected lots have expiration dates ranging from December 22, 2020, to January 9, 2021.
Hospitals nationwide that received the product should check their inventory for the specific lot numbers listed in the recall notice. Patients who have already received the medication should consult their healthcare provider if they have concerns about the product's sterility or integrity.
The recalled product
- Product
- PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Affected units
- 3,152
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 # 1220023003
- BUD 12/22/2020
- 1220023057
- BUD 12/25/2020
- 1220023104
- 1220023144
- BUD 12/27/2020
- 1220023168
- BUD 12/27/2020
- 1220023222
- BUD 12/29/2020
- 1220023240
- BUD 12/28/2020
- 1220023284
- BUD 1/1/2021
- 1220023456
- BUD 1/8/2021
- 1220023474
- BUD 1/4/2021
- 1220023530
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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