Drug 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.
D-0953-2017
Product summary
- Event
- Event 77595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2350 units
- Official record key
drug-enforcement:D-0953-2017
Official wording
Reason: Lack of Assurance of Sterility
Code 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.
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility