Why it was recalled
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Product description
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Lot numbers, UPCs & expiration codes
Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019
Where it was sold
1 vial was distributed to a medical facility in Mayville, NY.
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-0245-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 26, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 1 vial
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0245-2019, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81554
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019
- Postal code
- 15701-3571
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0245-2019
- Classification
- Class III
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 1 vial
- Termination date
- Feb 5, 2019
- Reason for recall
- Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
- Distribution pattern
- 1 vial was distributed to a medical facility in Mayville, NY.
- Recall initiation date
- Oct 26, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2018