Why it was recalled
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Product description
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
Lot numbers, UPCs & expiration codes
Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
Where it was sold
Nationwide and Puerto Rico
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-012-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 24, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 251,400 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-012-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66422
- Address
- 275 N Field Dr
- Code information
- Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
- Postal code
- 60045-2579
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-012-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 251,400 vials
- Termination date
- Oct 6, 2014
- Reason for recall
- Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 24, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2013