Class II · Moderate risk Terminated
Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling; Missing label; ampoules are missing the immediate container label
What was recalled
Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-1203-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1226-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Meperidine recalls
See all
Class II · Moderate risk Terminated
Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Meperidine 100mg/ml MDV, 5ml 90 day expiration,
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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