Dr. Reddy's Laboratories, Inc.: 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 Limite

Is my product affected?

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

• Brand LEVETIRACETAM

Check against the official notice below — it lists the full affected range.

What happened

Dr. Reddy's Laboratories is recalling Levetiracetam in 0.54% Sodium Chloride Injection 1,500 mg/100mL manufactured by Gland Pharma Limited. The recall affects 2,770 bags (277 selling units) of lot ABD807 with an expiration date of 05/2020 that were distributed nationwide. The infusion bags have a labeling error in which the pre-printed text on the primary bag and the NDC number incorrectly identify the product as containing 0.75% Sodium Chloride with a strength of 1,000 mg/100mL, while the external foil pouch correctly identifies the actual product as containing 0.54% Sodium Chloride with a strength of 1,500 mg/100mL.

The recall source does not specify what consumers should do regarding this recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

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: Nationwide Quantity: 2770 bags; 277 selling units Lot/code info: ABD807, exp 05/2020

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.2018-03-27
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