Recalls / Class II
Class IID-012-2014
Product
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
- Brand name
- Metoclopramide
- Generic name
- Metoclopramide
- Active ingredient
- Metoclopramide Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 0409-3414
- FDA application
- ANDA073118
- Affected lot / code info
- Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
Why it was recalled
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 251,400 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-09-24
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2014-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-012-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.