Multi-event September 2015 FDA Recall Drug by Bedford Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Bedford Pharmacy on September 22, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in NH, MA and the recall is currently terminated.

Reported Recall Events

D-0042-2016 TERMINATED D-0048-2016 TERMINATED D-0049-2016 TERMINATED D-0041-2016 TERMINATED D-0052-2016 TERMINATED D-0045-2016 TERMINATED D-0040-2016 TERMINATED D-0046-2016 TERMINATED D-0051-2016 TERMINATED D-0044-2016 TERMINATED D-0047-2016 TERMINATED D-0043-2016 TERMINATED D-0050-2016 TERMINATED

Recall Number: D-0042-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 09012015@3, Exp 10/16/2015

Recall Number: D-0048-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 08182015@6, Exp 10/02/2015

Recall Number: D-0049-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 09082015@4, Exp 10/23/2015

Recall Number: D-0041-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 08132015@9, Exp 09/27/2015

Recall Number: D-0052-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 08122015@11, Exp 09/26/2015

Recall Number: D-0045-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 07232015@1, Exp 09/06/29015

Recall Number: D-0040-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 09102015@9, Exp 10/25/15

Recall Number: D-0046-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 09082015@12, Exp10/23/2015; 09032015@16, Exp 10/18/2015

Recall Number: D-0051-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 08262015@9, Exp 10/10/2015

Recall Number: D-0044-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 08042015@3, Exp 09/18/2015

Recall Number: D-0047-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
2 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 09032015@16 , Exp 10/18/2015

Recall Number: D-0043-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 08132015@17, Exp 09/27/2015

Recall Number: D-0050-2016

Reason for Recall
Lack of assurance of sterility
Initiated
09-22-2015
Reported
10-21-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72233
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.
Bedford 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.
NH, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2016
Product Description About Product Description
Full technical description of the product.
P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Batch or Lot Expiration Information

Lot# : 07112015@5, Exp 09/29/2015