QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b...
FDA Drug Recall #D-0953-2017 — Class II — June 22, 2017
Recall Summary
| Recall Number | D-0953-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Pharma Inc. |
| Location | Houston, TX |
| Product Type | Drugs |
| Quantity | 2350 units |
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide with the United States
Lot / 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.
Other Recalls from Advanced Pharma Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1251-2019 | Class II | HYDROmorphone 20 mg/100 mL Injectable Solution,... | Apr 26, 2019 |
| D-1026-2019 | Class II | 2% Lidocaine HCl Injectable Solution, 60 mg/3 m... | Mar 13, 2019 |
| D-1017-2019 | Class II | fentaNYL 1000 mcg/100 mL Injectable Solution Fe... | Mar 13, 2019 |
| D-1031-2019 | Class II | Heparin 5,000 Units/5mL (1,000 Units per mL) In... | Mar 13, 2019 |
| D-1033-2019 | Class II | Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectab... | Mar 13, 2019 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.