FDAClass IIJanuary 21, 2015

Glycopyrrolate injection recall: Labeling Error

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…

Why was Glycopyrrolate injection recalled?

Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
SCA Pharmaceuticals
Quantity
972 syringes
Distribution
Louisiana
Recall date
January 21, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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