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Recall Observatory FDA recall evidence

Drug product

Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15

D-0129-2018

August 10, 2017

Class II

Product summary

Firm
Premier Pharmacy Labs Inc
Event
Event 77979
Status
Terminated
Classification
Class II
Quantity
1610 syringes
Official record key
drug-enforcement:D-0129-2018

Official wording

Reason: Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.

Code information: Lot # NEO071317MMDSA BUD: 01/19/2018 Lot # NEO071317MMDSC BUD: 01/19/2018 Lot # NEO071317MMDSF BUD: 01/19/2018

Distribution pattern: Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling error