Multi-event August 2018 FDA Recall Drug by Westlab Pharmacy, Inc. Dba Westlab Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Westlab Pharmacy, Inc. Dba Westlab Pharmacy on August 10, 2018 for the product Drug. The FDA reported the reason for recall as lack of process controls. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0090-2019 TERMINATED D-0089-2019 TERMINATED D-0091-2019 TERMINATED

Recall Number: D-0090-2019

Reason for Recall
Lack of Process Controls
Initiated
08-10-2018
Reported
10-31-2018
Quantity
222 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80838
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.
Westlab Pharmacy, Inc. dba Westlab Pharmacy
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05

Batch or Lot Expiration Information

Lot# Lot: 06182018@30 Exp. 08/28/2018

Recall Number: D-0089-2019

Reason for Recall
Incorrect Product Formulation
Initiated
08-10-2018
Reported
10-31-2018
Quantity
80 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80838
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.
Westlab Pharmacy, Inc. dba Westlab Pharmacy
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

Batch or Lot Expiration Information

Lot# Lot: 03192018@42 Discard after 9/15/2018

Recall Number: D-0091-2019

Reason for Recall
Lack of Process Controls
Initiated
08-10-2018
Reported
10-31-2018
Quantity
7 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80838
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.
Westlab Pharmacy, Inc. dba Westlab Pharmacy
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

Batch or Lot Expiration Information

Lot# Lot: 07262018@7 Exp. 08/25/2018