Why it was recalled
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Product description
Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52
Lot numbers, UPCs & expiration codes
ABD807, exp 05/2020
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-0485-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 26, 2018
- FDA report date
- Feb 20, 2019
- Quantity
- 2770 bags; 277 selling units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0485-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81441
- Address
- 107 College Rd E
- Code information
- ABD807, exp 05/2020
- Postal code
- 08540-6623
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0485-2019
- Classification
- Class I
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2770 bags; 277 selling units
- Termination date
- Apr 4, 2023
- Reason for recall
- Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 26, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2019