Agency classClass IIOur severity:Severe FDA (Drugs)·D-0216-2021·Announced 2021-01-13

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.

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. 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
Hazard: lack-of-sterility
defective-cap
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.

See all 32 products in this recall →

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Same hazard · lack of sterility