FDA Drug recall D-0485-2019
Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufac…
- FDA Drug
- Class I
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class I recall of Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufac… by Dr Reddy S Laboratories, citing 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 Chlori….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0485-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-10-26 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
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
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).
Identifiers
| upc | 343598637525 |
|---|---|
| ndc | 43598-635-52 |
| ndc | 43598-635-10 |
| ndc | 43598-636-52 |
| ndc | 43598-636-10 |
| ndc | 43598-637-52 |
| ndc | 43598-637-10 |
| ndc | 3435986375 |
| code_info | ABD807, exp 05/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.