Why it was recalled
Labeling; Missing label; ampoules are missing the immediate container label
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 221303A, 1OCT2014
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-1226-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 25, 2014
- FDA report date
- Apr 16, 2014
- Quantity
- 237,850 ampoules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1226-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67750
- Address
- 275 N Field Dr
- Code information
- Lot: 221303A, 1OCT2014
- Postal code
- 60045-2579
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1226-2014
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 237,850 ampoules
- Termination date
- Dec 18, 2015
- Reason for recall
- Labeling; Missing label; ampoules are missing the immediate container label
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 25, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2014