The Recall Desk
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.

What this means for you

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: