New Delhi: In another instance of recall of drugs made in India, 62,555 bottles of Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market.
This nationwide Class II recall is on account of "the original manufacturer's recall, in which the firm did not adequately investigate customer complaints," the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles), it added.
As per the report, the voluntary recall initiated on April 29, 2015 is ongoing.
Antibiotic Azithromycin is used for treatment of bacterial infections.
As per the USFDA website, a Class II recall is made in a "situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
New Delhi: In another instance of recall of drugs made in India, 62,555 bottles of Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market.
This nationwide Class II recall is on account of "the original manufacturer's recall, in which the firm did not adequately investigate customer complaints," the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles), it added.
As per the report, the voluntary recall initiated on April 29, 2015 is ongoing.
Antibiotic Azithromycin is used for treatment of bacterial infections.
As per the USFDA website, a Class II recall is made in a "situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
New Delhi: In another instance of recall of drugs made in India, 62,555 bottles of Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market.
This nationwide Class II recall is on account of "the original manufacturer's recall, in which the firm did not adequately investigate customer complaints," the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles), it added.
As per the report, the voluntary recall initiated on April 29, 2015 is ongoing.
Antibiotic Azithromycin is used for treatment of bacterial infections.
As per the USFDA website, a Class II recall is made in a "situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
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