The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public of the recall of various products by three drug manufacturing companies in the United States.
According to recent information by the U.S. Food and Drug Administration (FDA), leading pharmaceutical firms in India, Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus, are recalling multiple drug products in the U.S. market due to manufacturing-related problems.
Glenmark Recall Details
The Mumbai-based Glenmark Pharmaceuticals has initiated a Class II recall for over 25 drug products that had discrepancies against the current good manufacturing practices (CGMP); the recall started on March 13 from its U.S. subsidiary, Glenmark Pharmaceuticals Inc. (New Jersey).
These include Propafenone Hydrochloride ER capsules (for the irregular heartbeat), Solifenacin Succinate Tablets (for overactive bladder), Voriconazole Tablets (an antifungal drug), as well as neurotherapeutic medications like Lacosamide, Frovatriptan Succinate, and Rufinamide Tablets. The recall is class II, which involves products that pose temporary or medically reversible damage to health and a low risk for serious consequences.
A full list of the recalled medications is available here on this link: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96474
Sun Pharma Recall Details
Sun Pharmaceutical Industries Inc., through its US-based unit, initiated a Class III recall of Gabapentin capsules. Approximately 13,700 bottles were withdrawn due to cross-contamination risks. The medicine is widely used for treating epilepsy and nerve-related pain. Despite the lower recall severity, such actions highlight quality assurance lapses.
Zydus Pharmaceuticals Recall Details
Zydus Pharmaceuticals (USA) Inc. has recalled 3,144 bottles of Chlorpromazine Hydrochloride Tablets (USP 10 mg) — a medication commonly prescribed for psychiatric disorders like schizophrenia and bipolar disorder.
The recall was initiated due to CGMP deviations. Specifically, the batch contained levels of N-Nitroso-Dimethyl Chlorpromazine impurity (which is a Nitrosamine Drug Substance-Related Impurities (NDSRIS)) exceeding the interim safety limits recommended by regulatory authorities. Consumption of the affected product may carry a potential risk of carcinogenicity, which is considered a general characteristic of Nitrosamine compounds. This is categorised as a Class II recall and began on April 3, 2025.
Product: Chlorpromazine Hydrochloride Tablets, USP 10 mg, 100’s Count
NDC Number: 70710-1129-1
Lot Number: Z400069
Expiration Date: 12/2025
Distribution Dates: 05/2024 – 02/2025
Summary of Recalled products from the three Drug Manufacturers
Company | Product(s) Recalled | Recall Class | Reason for Recall | Units Affected |
Glenmark | Propafenone, Solifenacin, Voriconazole, Lacosamide, etc. | II | CGMP Deviations | 25+ Products |
Sun Pharma | Gabapentin Capsules | III | Cross-Contamination Concerns | 13,700 bottles |
Zydus | Chlorpromazine Tablets 10mg | II | Harmful Impurity Detected | 3,144 bottles |
Risk Statement:
The administration of contaminated drugs poses significant risks to human health. The impact of such contamination can range from mild adverse reactions to severe, and life-threatening conditions.
Although the products are not in the NAFDAC database, NAFDAC urges importers, distributors, retailers, healthcare providers, and patients to exercise caution and vigilance throughout the supply chain. This is essential to prevent the importation, distribution, sale, administration, or use of recalled products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the affected product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……….Customer-focused, Agency-minded!!!
