Multi-event September 2012 FDA Recall Drug by New England Compounding Center

This Multi-event Class II drug recall was voluntarily initiated by New England Compounding Center on September 26, 2012 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-122-2013 TERMINATED D-118-2013 TERMINATED D-119-2013 TERMINATED D-108-2013 TERMINATED D-112-2013 TERMINATED D-114-2013 TERMINATED D-111-2013 TERMINATED D-120-2013 TERMINATED D-110-2013 TERMINATED D-123-2013 TERMINATED D-121-2013 TERMINATED D-117-2013 TERMINATED D-115-2013 TERMINATED D-109-2013 TERMINATED D-124-2013 TERMINATED D-116-2013 TERMINATED D-113-2013 TERMINATED

Recall Number: D-122-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
8919 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-118-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
10,865 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-119-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
7055 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-108-2013

Reason for Recall
Non-Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
23,897 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All Lot codes

Recall Number: D-112-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-114-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-111-2013

Reason for Recall
Non-Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
3822 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-120-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-110-2013

Reason for Recall
Non-Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
5130 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-123-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
54 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-121-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
3,321 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-117-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
165 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-115-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
2747 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-109-2013

Reason for Recall
Non-Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
9062 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-124-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
56,655 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-116-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
20 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-113-2013

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-26-2012
Reported
01-09-2013
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63305
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.
New England Compounding Center
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA

Batch or Lot Expiration Information

Lot# All lot codes