CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Succinylcholine Chloride Injection, USP 200 mg recalled
Hospira a Pfizer is recalling Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, distributed in Puerto Rico. The recall was initiated on 15 Jun 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1048-2017
- FDA event ID
- 77533
- Recalling firm
- Hospira a Pfizer, Rocky Mount, NC
- Brand
- Quelicin
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2017
- FDA classified
- 1 Aug 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Jun 2017 | Recall initiated by company | |
| 1 Aug 2017 | Classified by FDA | +47 days |
| 9 Aug 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Sterility Assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).
Where it was distributed
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance
Which lots are affected?
a.) one vial Lot: 74393EV Exp. 05/01/2018 Lot: 75157EV Exp. 06/01/2018 Lot: 75367EV, Exp. 06/01/2018 b.) 25 vial carton Lot: 75158EV; Exp. 06/01/2018
Where was it sold?
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 77533This product is part of a recall event; the main page for the event is 8.4% Sodium Bicarbonate Inj., USP Single-dose, 50 mEq recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 8.4% Sodium Bicarbonate Inj., USP Single-dose, 50 mEq recalled | Hospira a Pfizer | Sterility | PR | |
| CLASS II | Potassium Phosphates Inj., USP P/mL) Also contains recalled | Hospira a Pfizer | Sterility | PR | |
| CLASS II | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution recalled | Hospira a Pfizer | Sterility | PR |
More recalls from Hospira a Pfizer
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution recalled | Hospira a Pfizer | Sterility | PR |
| Drug | CLASS II | Potassium Phosphates Inj., USP P/mL) Also contains recalled | Hospira a Pfizer | Sterility | PR |
| Drug | CLASS II | 8.4% Sodium Bicarbonate Inj., USP Single-dose, 50 mEq recalled | Hospira a Pfizer | Sterility | PR |
Other Succinylcholine Chloride recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Succinylcholine Chloride Injection, USP 200 mg/ (20 mg/mL) recalledSuccinylcholine Chloride | Zydus Pharmaceuticals | Potency & Assay | 4 states |
| Drug | CLASS II | SUCcinylcholine Chloride 200 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCcinylcholine Chloride 100 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCCINYLcholine Chloride 200 mg/ (20 mg/mL) BD Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg recalled | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |