Multi-event June 2017 FDA Recall Drug by Advanced Pharma Inc.
This Multi-event Class II drug recall was voluntarily initiated by Advanced Pharma Inc. on June 9, 2017 for the product Drug. The FDA reported the reason for recall as stability data does not support expiry. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0116-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
06-09-2017
12-27-2017
4800 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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Batch or Lot Expiration Information
Lot# Lot: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17
Recall Number: D-0113-2018
Subpotent Drug: found to be below the specification for labeled assay.
06-09-2017
12-27-2017
550 syringes
Recall Profile & Regulatory Data
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.
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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Batch or Lot Expiration Information
Lot# Lot: 4/17/17 0857 81861S, BUD 08/15/2017
Recall Number: D-0114-2018
Subpotent Drug: found to be below the specification for labeled assay.
06-09-2017
12-27-2017
320 syringes
Recall Profile & Regulatory Data
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.
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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
Batch or Lot Expiration Information
Lot# Lot: 4/10/17 1441 257-86367S, BUD 6/9/17; 4/17/17 0950 86367S, BUD¿6/16/2017; 4/20/17 1505 257-86367S, BUD 6/19/2017; 4/24/17 0115 15-86367S, BUD ¿6/23/2017; 4/26/17 0301 387-86367S, BUD 6/25/2017
Recall Number: D-0117-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
06-09-2017
12-27-2017
50 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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
Batch or Lot Expiration Information
Lot# Lot: 5/31/17 0202 5-81862S, BUD 7/30/17
Recall Number: D-0119-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
06-09-2017
12-27-2017
550 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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
Batch or Lot Expiration Information
Lot# Lot: 4/20/17 0307 265-86361S, BUD 6/19/17; 4/26/17 0732 265-86361S, BUD 6/25/17; 4/28/17 0215 265-86361S, BUD 6/27/17; 5/2/17 0310 248-86361S, BUD 7/1/17; 5/4/17 1422 248-86361S, BUD 7/3/17; 5/12/17 0841 248-86361S, BUD 7/11/17; 5/18/17 0206 250-86361S, BUD 7/17/17
Recall Number: D-0118-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
06-09-2017
12-27-2017
680 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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
Batch or Lot Expiration Information
Lot# Lot: 4/26/17 0730 20-86367S, BUD 6/25/17; 4/24/17 0106 241-86367S, BUD 6/23/17; 5/1/17 1500 45-86367S, BUD 6/30/17; 5/9/17 1103 241-86367S, BUD 7/8/17; 5/9/17 1104 257-86367S, BUD 7/8/17; 5/12/17 0839 15-86367S, BUD 7/11/17; 5/19/17 0109 15-86367S, BUD 7/18/17; 5/22/17 0828 387-86367S, BUD 7/21/17; 5/23/17 0721 257-86367S, BUD 7/22/17; 5/24/17 0200 241-86367S, BUD 7/23/17; 5/24/17 0203 20-86367S, BUD 7/23/17; 5/26/17 0315 15-86367S, BUD 7/25/17; 5/31/17 1217 20-86367S, BUD 7/30/17
Recall Number: D-0115-2018
Subpotent Drug: found to be below the specification for labeled assay.
06-09-2017
12-27-2017
50 syringes
Recall Profile & Regulatory Data
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.
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.
Advanced Pharma Inc.
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 to hospitals and medical facilities.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
Batch or Lot Expiration Information
Lot# Lot: 4/19/17 1445 248-86361S, BUD¿6/18/2017
