Multi-event February 2016 FDA Recall Drug by Walter's Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Walter's Pharmacy on February 12, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in PA and the recall is currently terminated.

Reported Recall Events

D-0798-2016 TERMINATED D-0793-2016 TERMINATED D-0792-2016 TERMINATED D-0795-2016 TERMINATED D-0797-2016 TERMINATED D-0794-2016 TERMINATED D-0791-2016 TERMINATED D-0786-2016 TERMINATED D-0787-2016 TERMINATED D-0790-2016 TERMINATED D-0796-2016 TERMINATED D-0789-2016 TERMINATED D-0788-2016 TERMINATED

Recall Number: D-0798-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60

Batch or Lot Expiration Information

Lot# : 020216

Recall Number: D-0793-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
22 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09

Batch or Lot Expiration Information

Lot# : 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516.

Recall Number: D-0792-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
4 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78

Batch or Lot Expiration Information

Lot# : 012216, 012616, 012816, 020316, 020616

Recall Number: D-0795-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47

Batch or Lot Expiration Information

Lot# : 012116, #012516

Recall Number: D-0797-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54

Batch or Lot Expiration Information

Lot# : 020216

Recall Number: D-0794-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33

Batch or Lot Expiration Information

Lot# : 012116, 012516

Recall Number: D-0791-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35

Batch or Lot Expiration Information

Lot# : 020316 and 011216

Recall Number: D-0786-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
4 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04

Batch or Lot Expiration Information

Lot# : 012216, 012816, 012616, 020616

Recall Number: D-0787-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47

Batch or Lot Expiration Information

Lot# : 012516, 020516

Recall Number: D-0790-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92

Batch or Lot Expiration Information

Lot# 012516

Recall Number: D-0796-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
5 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61

Batch or Lot Expiration Information

Lot# : 020216

Recall Number: D-0789-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706

Batch or Lot Expiration Information

Lot# : 012516

Recall Number: D-0788-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-12-2016
Reported
04-06-2016
Quantity
5 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73336
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.
Walter's 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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99

Batch or Lot Expiration Information

Lot# : 010516, 012016