D-0485-2019 Class I Terminated
FDA drug recall D-0485-2019 was initiated by Dr. Reddy's Laboratories, Inc. on Oct 26, 2018 and is designated Class I. 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)… The recall status is terminated (terminated Apr 4, 2023). Affected quantity: 2770 bags; 277 selling units.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 20, 2019
- Initiation Date
- Oct 26, 2018
- Termination Date
- Apr 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2770 bags; 277 selling units
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
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).
Distribution Pattern
Nationwide
Code Information
ABD807, exp 05/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0485-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026