Why it was recalled
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Product description
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)
Lot numbers, UPCs & expiration codes
Lot # 31325335B, exp. date 07/2021
Where it was sold
Nationwide, including 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-0297-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2021
- FDA report date
- Mar 10, 2021
- Quantity
- 9,452 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0297-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87330
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 31325335B, exp. date 07/2021
- Postal code
- 07054-1120
- Report date
- Mar 10, 2021
- Product type
- Drugs
- Recall number
- D-0297-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 9,452 cartons
- Termination date
- Aug 26, 2021
- Reason for recall
- Chemical contamination; Unknown brown residue adhering to the inside of one vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)
- Distribution pattern
- Nationwide, including Puerto Rico
- Recall initiation date
- Feb 15, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2021