FDAClass IIJuly 19, 2017

Quelicin recall: Sterility Concern

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…

Why was Quelicin recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
Advanced Pharma Inc.
Quantity
2350 units
Distribution
Nationwide with the United States
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls