The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0194-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential sterility issues.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only. 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 specific lots involved are 1220023043 (BUD 2/3/2021), 1220023141 (BUD 2/9/2021), 1220023429 (BUD 2/18/2021), and 1220023470 (BUD 2/18/2021). The product is identified by barcode 70004063809.

Healthcare facilities should check their inventory for these specific lot numbers and discontinue use if found. Patients who have received this medication should contact their healthcare provider for further instructions.

The recalled product

Product
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injectable
Hazard
Affected units
1,614

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 (7)

  • Lot # 1220023043
  • BUD 2/3/2021
  • 1220023141
  • BUD 2/9/2021
  • 1220023429
  • BUD 2/18/2021 & 1220023470
  • BUD 2/18/2021.

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 →

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