Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, ...
FDA Drug Recall #D-0836-2016 — Class III — March 15, 2016
Recall Summary
| Recall Number | D-0836-2016 |
| Classification | Class III — Low risk |
| Date Initiated | March 15, 2016 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Drugs |
| Quantity | 103,600 vials |
Product Description
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Distribution Pattern
Nationwide
Lot / Code Information
Lot 52-045-EV, Exp 07/1/2016
Other Recalls from Hospira Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0862-2017 | Class I | Infant 25% DEXTROSE Injection, USP, 2.5 g (250 ... | Apr 21, 2017 |
| D-0153-2017 | Class II | Fentanyl Citrate Injection, USP, 100 mcg Fentan... | Nov 1, 2016 |
| D-1500-2016 | Class II | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL V... | Aug 15, 2016 |
| D-0169-2017 | Class III | 5% Lidocaine HCL and 7.5% Dextrose Injection, U... | Jun 29, 2016 |
| D-1359-2016 | Class II | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL)... | Jun 23, 2016 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
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.