June 2021 FDA Recall Drug by Promise Pharmacy, Llc
D-0803-2021 - Lack of processing controls

This Class II drug recall was voluntarily initiated by Promise Pharmacy, Llc on June 30, 2021 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in AZ, CO, FL, IL, NJ and the recall is currently terminated.

Recall Number: D-0803-2021

Reason for Recall
Lack of processing controls
Initiated
06-30-2021
Reported
09-22-2021
Quantity
57 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88662
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.
Promise Pharmacy, LLC
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, CO, FL, IL, NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-06-2023
Product Description About Product Description
Full technical description of the product.
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS

Batch or Lot Expiration Information

Lot# 06152021@2, Exp 09/13/2021