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Recall Observatory FDA recall evidence

Drug 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

D-0339-2015

January 02, 2015

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 70167
Status
Terminated
Classification
Class II
Quantity
972 syringes
Official record key
drug-enforcement:D-0339-2015

Official wording

Reason: 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".

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

Distribution pattern: Louisiana

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or missing