The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0339-2015·Announced 2015-01-21

SCA Pharmaceuticals Recalls Glycopyrrolate Injection Due to Labeling Error

SCA Pharmaceuticals is recalling 972 syringes of Glycopyrrolate injection distributed in Louisiana because a printing error made the expiration date appear incorrect.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a minor labeling error (printing overlap) without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 972 syringes of Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe. The affected product was distributed in Louisiana. The recall involves two specific lots: 20141218@41 with a use-by date of 3/18/2015, and 20141226@24 with a use-by date of 3/26/2015.

The recall was initiated due to a labeling defect. A printing error caused the characters "y" and "3" to overlap, making the actual "Use By 3/2015" date appear to read "Use By 8/2015". This discrepancy could lead to the use of expired medication.

Consumers and healthcare providers who have this product should stop using it and contact SCA Pharmaceuticals at 877-550-5059 for further instructions. The product is prescription-only.

The recalled product

Product
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059
Affected units
972

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 (4)

  • Lot #: 20141218@41
  • Use by 3/18/2015
  • 20141226@24
  • Use by 3/26/2015

Distribution

Distributed in 1 state:

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