The Recall Desk
SevereFDA (Drugs)·D-0210-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 14,580 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 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 14,580 syringes of Phenylephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride. The product is a prescription-only, 5 mL single-dose syringe manufactured by SCA Pharmaceuticals in Windsor, Connecticut.

The recall was initiated 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 lots have expiration dates ranging from January 20, 2021, to February 4, 2021.

The product was distributed to hospitals nationwide. Healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected product. Consumers should not use the product if they have it in their possession and should contact their healthcare provider for guidance.

The recalled product

Product
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injectable
Hazard
Affected units
14,580

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 # 1220022958
  • BUD 1/20/2021
  • 1220023013
  • BUD 1/18/2021
  • 1220023035
  • BUD 1/19/2021
  • 1220023036
  • BUD 1/21/2021
  • 1220023059
  • 1220023094
  • BUD 1/25/2021
  • 1220023167
  • BUD 1/26/2021
  • 1220023208
  • BUD 1/27/2021
  • 1220023291
  • BUD 1/31/2021
  • 1220023359
  • BUD 2/2/2021
  • 1220023401

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

Same manufacturer · SCA Pharmaceuticals

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Same hazard · sterility

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