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 22, 2017 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-0956-2017 TERMINATED D-0953-2017 TERMINATED D-0954-2017 TERMINATED D-0955-2017 TERMINATED

Recall Number: D-0956-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
06-22-2017
Reported
07-19-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77595
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.
Advanced Pharma Inc.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25

Batch or Lot Expiration Information

Lot# : 6/7/17 1446 515-92225P BUD: 9/5/2017; 6/2/17 1100 515-92225P BUD: 8/31/2017; 5/31/17 1415 382-92225P BUD: 8/29/2017.

Recall Number: D-0953-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
06-22-2017
Reported
07-19-2017
Quantity
2350 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77595
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.
Advanced Pharma Inc.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.

Batch or Lot Expiration Information

Lot# : a) 5/15/17 2305 81467S, BUD 7/29/2017; 5/22/17 1000 81467S, BUD 8/5/2017; 5/30/17 1549 81467S,BUD 8/13/2017. b) 5/24/17 0307 169-81479S, BUD 7/23/2017; 5/18/17 0220 169-81479S, BUD 7/17/2017; 5/16/17 0306 169-81479S, BUD 7/15/2017; 6/5/17 0937 169-81479S, BUD 8/04/2017; 5/16/17 0314 445-81479S, BUD 7/15/2017; 5/16/17 0315 493-81479S, BUD 7/15/2017; c) 5/15/17 2119 81461S, BUD 7/29/2017; 5/22/17 0922 81461S, BUD 8/5/2017; 5/30/17 1533 81461S, BUD 8/13/2017; 6/12/17 1846 81461S, BUD 8/26/2017; 6/5/17 0237 157-81461SB, BUD 8/4/2017.

Recall Number: D-0954-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
06-22-2017
Reported
07-19-2017
Quantity
72 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77595
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.
Advanced Pharma Inc.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25

Batch or Lot Expiration Information

Lot# : 5/23/17 1404 299-92625P, BUD: 8/21/2017; 5/26/2017 1250 297-92625P, BUD 8/24/2017.

Recall Number: D-0955-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
06-22-2017
Reported
07-19-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77595
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.
Advanced Pharma Inc.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25

Batch or Lot Expiration Information

Lot# : 5/31/17 1416 382-92425P BUD: 8/29/2017