Multi-event September 2019 FDA Recall Drug by Compounded Solutions In Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Compounded Solutions In Pharmacy on September 3, 2019 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in Product was dispensed to patients and the recall is currently terminated.

Reported Recall Events

D-1855-2019 TERMINATED D-1854-2019 TERMINATED D-1853-2019 TERMINATED

Recall Number: D-1855-2019

Reason for Recall
Lack of Processing Controls:
Initiated
09-03-2019
Reported
09-18-2019
Quantity
a) 4x5 ml, b) 1x10 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83722
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.
Compounded Solutions in 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was dispensed to patients
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-04-2020
Product Description About Product Description
Full technical description of the product.
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

Batch or Lot Expiration Information

Lot# Lots a) 07182019@29 exp: 8/31/19, 07082019@2 exp: 8/31/19, 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19; b) 07022019@28 exp: 8/31/19

Recall Number: D-1854-2019

Reason for Recall
Lack of Processing Controls:
Initiated
09-03-2019
Reported
09-18-2019
Quantity
a) 6x5ml b) 4x10 c) 1x15 ml bottles,

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83722
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.
Compounded Solutions in 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was dispensed to patients
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-04-2020
Product Description About Product Description
Full technical description of the product.
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

Batch or Lot Expiration Information

Lot# Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19

Recall Number: D-1853-2019

Reason for Recall
Lack of Processing Controls:
Initiated
09-03-2019
Reported
09-18-2019
Quantity
3x3 ml dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83722
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.
Compounded Solutions in 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was dispensed to patients
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-04-2020
Product Description About Product Description
Full technical description of the product.
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.

Batch or Lot Expiration Information

Lot# Lots: 07172019@39 exp: 8/31/19, Rx # 215042 06192019@28 exp: 7/03/19, Rx # 219335 06052019@8 exp: 6/19/19; Rx # 222826