Generics from other manufacturers have not been recalled. The recall is a small positive for Pfizer, which makes branded Lipitor. Pfizer has a generic drug division named Greenstone and some consumers might feel most comfortable asking for the Greenstone generic Lipitor.
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Ranbaxy announced today that it was recalling a large number of batches of its generic Lipitor as they might include very small glass particles - something that could be dangerous if ingested. Ingesting glass does not lower your cholesterol, but patients taking Ranbaxy's generic version of Pfizer 's blockbuster cholesterol-lowering drug Lipitor might be doing just that.
Daiichi Sanko acquired a nearly 70% stake in Ranbaxy for approximay $4.8 billion according to Sankyo materials in 2008, with an initial price of approximay Rs 737 per share.
Dr Reddy's has initiated voluntary recall of over 80000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US.
Dr Reddy’s officials were not immediay available for comment.
Mometasone Furoate Cream is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
The product is being recalled through three separate letters to the drug regulator.
The product was manufactured at the drug maker’s Srikakulam plant in Andhra Pradesh. The drug is being recalled under “not yet classified” category which, according to the FDA, means that a firm’s action meets the definition of a recall, however, the FDA has not completed its assessment of the hazard posed by the recalled product(s) yet, and is considered a pending classification.
Atorvastatin is a drug that blocks the production of cholesterol and reduces its level in the blood.
Hyderabad: Dr Reddy’s Laboratories has initiated voluntary recall of over 80,000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US market due to quality concerns.
Meanwhile, Glenmark Pharmaceuticals in a separate letter also initiated voluntary recall of 5,136 tunes of its Mometasone Furoate Cream, USP, 0.1% 45gm from the US market due to violations of the CGMP (current good manufacturing practice) regulations set up by the USFDA.
According to the USFDA, the reason for the recall was, “Failed Impurities/Degradations specifications; out-of-specification results observed for Total Degradation Impurities during stability.”
According to a notification issued by the US Food and Drug Administration (USFDA), multiple lots of Atorvastatin 10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market.
“Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification (Class I, II or III) indicating the hazard posed by the recalled product(s),” said FDA.
Greenstone initiated this recall because product from these lots has the potential to.. Ranbaxy Laboratories is recalling 10 mg tablets of atorvastatin calcium.
Please see the complete recall Safety Alert at: https://www.fda.gov/Safety/Recalls/ucm591975.htm.
Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of acetaminophen tablets with NDC #:. The Acetaminophen 500mg tablet 100 count over-the-counter bottle (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”
Clopidogrel Tablets USP, 75 mg by International Laboratories: recall - product mislabeling.
Consumers with questions regarding this recall can contact Amneal Pharmaceuticals at 631.952.0214 x338 or on Monday through Friday from 10 a.m.
Information about the prescription drugs manufactured by Greenstone Llc.
The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
However, it is not known whether dose adjustments are needed for hepatic disease with other etiologies (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
See full prescribing information for ATORVASTATIN CALCIUM TABLETS . NDC - 90 Tablets GREENSTONE BRAND atorvastatin - calcium.
A chemically similar drug in this class produced optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in clinically normal dogs in a dose-dependent fashion at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose. CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with other members of this class.
Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN.