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Recall Observatory FDA recall evidence

Drug product

Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03

D-0512-2016

November 11, 2015

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 72699
Status
Terminated
Classification
Class II
Quantity
60 Vials
Official record key
drug-enforcement:D-0512-2016

Official wording

Reason: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

Code information: Lot # B0077329-040215, Exp 07/2017; B0091342-070315, Exp 08/2017; B0109416-102815, Exp 03/2018

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect