DDA Drug Recall Notice | Substandard Injections Recalled
Published Date: 2082/02/26
The Department of Drug Administration (DDA) has issued this urgent notice following test results from the National Drug Laboratory. The following dosage forms (drugs) have been found to be of substandard quality. As per Section 14 of the Drug Act, 2035, these drugs are hereby ordered to be recalled immediately from the market and not to be distributed or used.
The concerned manufacturer, importer, and related stakeholders are informed to comply with this recall notice. The details are as follows:
Drugs to be Recalled:
1. RL 500 ML (Compound Sodium Lactate Injection IP)
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Batch No.: A0581030
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Manufacturing Date: October 2024
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Expiry Date: September 2026
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Reason for Recall:
“Does not comply as per IP 2022 with respect to sterility test performed” -
Manufacturer:
Lomus Parenterals and Formulation Pvt. Ltd.
Chireswarnath Municipality, Ward No. 1, Dhanusha, Nepal
2. D5 %, 500 ML (Dextrose 5% Injection USP)
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Batch No.: A0181004
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Manufacturing Date: November 2024
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Expiry Date: October 2026
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Reason for Recall:
“Does not comply as per USP 2024 with respect to sterility test performed” -
Manufacturer:
Lomus Parenterals and Formulation Pvt. Ltd.
Chireswarnath Municipality, Ward No. 1, Dhanusha, Nepal
