August 2017 FDA Recall Drug by Premier Pharmacy Labs Inc
D-0129-2018 - Stability Date Doesn't Support Expiry

This Class II drug recall was voluntarily initiated by Premier Pharmacy Labs Inc on August 10, 2017 for the product Drug. The FDA reported the reason for recall as stability date doesn't support expiry. The product was distributed in Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida and the recall is currently terminated.

Recall Number: D-0129-2018

Reason for Recall
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Initiated
08-10-2017
Reported
12-27-2017
Quantity
1610 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77979
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Premier Pharmacy Labs Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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