Recalls / Class II
Class IID-0953-2017
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 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 2350 units
- Distribution pattern
- Nationwide with the United States
Timeline
- Recall initiated
- 2017-06-22
- FDA classified
- 2017-07-07
- Posted by FDA
- 2017-07-19
- Terminated
- 2017-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0953-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.