Multi-event July 2016 FDA Recall Drug by Safecor Health, Llc

This Multi-event Class II drug recall was voluntarily initiated by Safecor Health, Llc on July 7, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in MA and NY and the recall is currently terminated.

Reported Recall Events

D-0903-2017 TERMINATED D-0902-2017 TERMINATED D-0905-2017 TERMINATED D-0901-2017 TERMINATED D-0904-2017 TERMINATED D-0900-2017 TERMINATED

Recall Number: D-0903-2017

Reason for Recall
CGMP Deviations
Initiated
07-07-2016
Reported
06-21-2017
Quantity
601 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74822
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.
Safecor Health, LLC
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.
MA and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2017
Product Description About Product Description
Full technical description of the product.
Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305

Batch or Lot Expiration Information

Lot# A25591, Exp. 02/22/2017

Recall Number: D-0902-2017

Reason for Recall
CGMP Deviations
Initiated
07-07-2016
Reported
06-21-2017
Quantity
25 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74822
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.
Safecor Health, LLC
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.
MA and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2017
Product Description About Product Description
Full technical description of the product.
Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.

Batch or Lot Expiration Information

Lot# A18705, Exp. 09/30/2017

Recall Number: D-0905-2017

Reason for Recall
CGMP Deviations
Initiated
07-07-2016
Reported
06-21-2017
Quantity
1,933 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74822
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.
Safecor Health, LLC
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.
MA and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2017
Product Description About Product Description
Full technical description of the product.
Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402

Batch or Lot Expiration Information

Lot# A25593, Exp. 02/22/2017

Recall Number: D-0901-2017

Reason for Recall
CGMP Deviations
Initiated
07-07-2016
Reported
06-21-2017
Quantity
119 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74822
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.
Safecor Health, LLC
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.
MA and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2017
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009

Batch or Lot Expiration Information

Lot# A18661, Exp. 10/31/2017

Recall Number: D-0904-2017

Reason for Recall
CGMP Deviations
Initiated
07-07-2016
Reported
06-21-2017
Quantity
856 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74822
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.
Safecor Health, LLC
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.
MA and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2017
Product Description About Product Description
Full technical description of the product.
Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205

Batch or Lot Expiration Information

Lot# A25593, Exp. 2/22/2017

Recall Number: D-0900-2017

Reason for Recall
CGMP Deviations
Initiated
07-07-2016
Reported
06-21-2017
Quantity
66 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74822
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.
Safecor Health, LLC
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.
MA and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2017
Product Description About Product Description
Full technical description of the product.
Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.

Batch or Lot Expiration Information

Lot# : A18688, Exp. 09/30/2018