CLASS III Drug recall · Reported 3 Apr 2013 · FDA Enforcement Report
Lactated Ringer's Injection recalled by Hospira
Hospira is recalling Lactated Ringer's Injection, USP, distributed in North Carolina. The recall was initiated on 21 Jun 2012 and the FDA has classified it as Class III.
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-215-2013
- FDA event ID
- 63242
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Jun 2012
- FDA classified
- 22 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Hidden Drug Ingredients
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Jun 2012 | Recall initiated by company | |
| 22 Mar 2013 | Classified by FDA | +274 days |
| 3 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Shipment of product not approved for release.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Where it was distributed
NC
Questions about this recall
Is Lactated Ringer's Injection, USP recalled?
Yes. Hospira recalled Lactated Ringer's Injection, USP on 21 Jun 2012. The recall is Class III and its status is Terminated. Recall number D-215-2013.
Why was it recalled?
CGMP Deviations: Shipment of product not approved for release.
Which lots are affected?
Lot 16-836-FW, Exp 04/14
Where was it sold?
NC
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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