Multi-event March 2015 FDA Recall Drug by Fallon Wellness Pharmacy, L.l.c.

This Multi-event Class II drug recall was voluntarily initiated by Fallon Wellness Pharmacy, L.l.c. on March 17, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in New York and the recall is currently terminated.

Reported Recall Events

D-1075-2015 TERMINATED D-1072-2015 TERMINATED D-1068-2015 TERMINATED D-1073-2015 TERMINATED D-1066-2015 TERMINATED D-1069-2015 TERMINATED D-1067-2015 TERMINATED D-1070-2015 TERMINATED D-1071-2015 TERMINATED D-1074-2015 TERMINATED

Recall Number: D-1075-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : a) 02092015@59, Exp 4/10/15; b) 02122015@49, Exp 4/13/15; c) 02132015@44, Exp 4/14/15; d) 02192015@34, Exp 4/20/15

Recall Number: D-1072-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : 12172014@42; Exp 4/12/15

Recall Number: D-1068-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
43 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : a) 10272014@1, Exp 4/27/15; b) 11042014@60, Exp 4/12/15; c) 11192014@43, Exp 4/12/15; d) 12042014@32, Exp 4/12/15; e) 12182014@46; Exp 4/12/15; f) 12232014@8, 12242014@16, Exp 4/12/15; g) 12312014@40, Exp 4/12/15

Recall Number: D-1073-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
8 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : 12302014@9; Exp 4/12/15

Recall Number: D-1066-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
30 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : 01272015@38, Exp 3/28/15

Recall Number: D-1069-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
15 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : a) 1031-2014@51; Exp 3/18/15; b) 12152014@24; Exp 4/12/15

Recall Number: D-1067-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
12 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : 02112015@35, Exp 4/12/15

Recall Number: D-1070-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
8 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : a) 11172014@75- Exp 4/12/2015

Recall Number: D-1071-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : 12012014@65; Exp 4/12/15

Recall Number: D-1074-2015

Reason for Recall
Lack of assurance of sterility
Initiated
03-17-2015
Reported
05-20-2015
Quantity
56 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70807
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.
Fallon Wellness Pharmacy, L.L.C.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2018
Product Description About Product Description
Full technical description of the product.
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Batch or Lot Expiration Information

Lot# : a) 02052015@53, Exp 4/6/15; b) 01142015@31, Exp 3/15/15; c) 02022015@6, Exp 4/3/15; d) 01132015@72, Exp 3/14/15; e) 01282015@57, Exp 3/29/15; f) 01302015@50, Exp 3/31/15; g) 01232015@14, Exp 3/24/15