Multi-event July 2023 FDA Recall Drug by New England Life Care, Inc. Dba Advanced Compounding Solutions
This Multi-event Class II drug recall was voluntarily initiated by New England Life Care, Inc. Dba Advanced Compounding Solutions on July 10, 2023 for the product Drug. The FDA reported the reason for recall as cgmp violations- that spaces adjacent to the production area may have been compromised at the time of production.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0928-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
07-10-2023
07-26-2023
500 Syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
New England Life Care, Inc. dba Advanced Compounding Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
Batch or Lot Expiration Information
Lot# 20230524-530F73, Exp 21OCT2023
Recall Number: D-0927-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
07-10-2023
07-26-2023
82 Bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
New England Life Care, Inc. dba Advanced Compounding Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
Batch or Lot Expiration Information
Lot# 20230524-6FBB77, Exp 21OCT2023
Recall Number: D-0929-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
07-10-2023
07-26-2023
209 Bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
New England Life Care, Inc. dba Advanced Compounding Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Batch or Lot Expiration Information
Lot# 20230524-0113AB, Exp 22AUG2023
Recall Number: D-0926-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
07-10-2023
07-26-2023
493 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
New England Life Care, Inc. dba Advanced Compounding Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
Batch or Lot Expiration Information
Lot# 20230524-23C29D, Exp 21SEP2023
