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Class III: unlikely to cause harmOngoing

Hospira Quelicin Recall

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg

Hospira Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
May 11, 2016
Recall ID
D-0836-2016
Check your lot numberHow we source this data

Summary

Hospira recalled Quelicin starting Mar 15, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0836-2016 on May 11, 2016. Reason: 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. Status: Ongoing.

Why it was recalled

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.

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

Lot numbers, UPCs & expiration codes

Lot 52-045-EV, Exp 07/1/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0836-2016
Classification
Class III
Status
Ongoing
Recall initiated
Mar 15, 2016
FDA report date
May 11, 2016
Quantity
103,600 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0836-2016, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Ongoing
Country
United States
Event ID
73647
Address
275 N Field Dr
Code information
Lot 52-045-EV, Exp 07/1/2016
Postal code
60045-2579
Report date
May 11, 2016
Product type
Drugs
Recall number
D-0836-2016
Classification
Class III
Recalling firm
Hospira Inc.
Product quantity
103,600 vials
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Mar 15, 2016
Initial firm notification
Letter
Center classification date
May 4, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0836-2016, published May 11, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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