December 2016 FDA Recall Drug by Meta Pharmacy Services
D-0227-2017 - Lack of Sterility Assurance
This Class II drug recall was voluntarily initiated by Meta Pharmacy Services on December 15, 2016 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed in One consignee in Las Vegas and the recall is currently terminated.
Recall Number: D-0227-2017
Lack of Sterility Assurance
12-15-2016
12-28-2016
150 mL
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Meta Pharmacy Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
One consignee in Las Vegas
01-17-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
Batch or Lot Expiration Information
Lot# Lot: 112716SB, Exp. 12/27/2016
