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Twelve prescription drugs were recalled in January and February to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
Such recalls are voluntary actions carried out by drug makers to remove potentially defective medicines from the market, the FDA said. They may be initiated either by the manufacturer or the FDA.
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Drug Recalls for January and February
| Date | Brand Name | Product
Description | Reason / Problem | Company |
| Feb. 28 | Camber Pharmaceuticals Inc. | Losartan Tablets USP 25 mg, 50 mg, and 100 mg | Contains N-Nitroso N-Methyl 4-amino butyric acid (NMBA) | Camber Pharmaceuticals Inc. |
| Feb. 25 | ChemoLock and ChemoClave | Vial Spikes | Due to the potential for burr particulate | ICU Medical Inc. |
| Feb. 22 | Macleods | Losartan Potassium/Hydrochlorothiazide Combination Tablets | Impurity N-nitroso-diethylamine (NDEA) | Macleods Pharmaceuticals Limited |
| Feb. 8 | McDaniel Life-Line | Indian Herb (topical) | Marketed without an approved NDA/ANDA | McDaniel Life-Line LLC |
| Feb. 4 | Dr. Reddy’s Laboratories Ltd. | Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection) | Mislabeling | Dr. Reddy’s Laboratories Ltd. |
| Jan. 29 | CVS, Equate | Oral ibuprofen | Higher levels of
ibuprofen concentration | Tris Pharma, Inc. |
| Jan. 22 | Torrent Pharmaceuticals Limited | “losartan potassium tablets, USP; losartan potassium hydrochlorothiazide combination tablets, USP” | Due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) | Torrent Pharmaceuticals Limited |
| Jan. 18 | Prinston Pharmaceutical Inc. dba Solco Healthcare LLC | Irbesartan and Irbesartan
HCTZ Tablets | Detection of a trace amount of unexpected impurity, N- nitrosodiethylamine (NDEA) | Prinston Pharmaceutical Inc. dba Solco Healthcare LLC |
| Jan. 8 | Rhino | Rhino 5K capsules | Unapproved new drug | Happy Together Inc. |
| Jan. 8 | Sun Pharma | Vecuronium Bromide for Injection | Particulate matter | Sun Pharmaceutical Industries Inc. |
| Jan. 5 | Lupin Pharmaceuticals Inc. | Ceftriaxone for Injection, USP | Due to products containing visual gray particulate matter in reconstituted vial | Lupin Pharmaceuticals Inc. |
| Jan. 3 | Torrent Pharmaceuticals Limited | Losartan potassium tablets, USP | Due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) | Torrent Pharmaceuticals Limited |
