Lupin Recalls Select Lots of the Antibiotic Ceftriaxone
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Lupin Pharmaceutical has voluntarily recalled 13 lots consisting of 54,472 vials in various dosage forms of the antiobiotic, ceftriaxone for injection, due to the intermediates of the active pharmaceutical ingredient (API) failing specifications. The lots were manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland by Lupin Limited in Mandideep, India. The notice was reported in the US Food and Drug Administration’s Weekly Enforcement Report of June 8, 2016.

The Class III recall applies to the US, including Puerto Rico, and was initiated on March 11, 2016 and is ongoing. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

The recall applies to the following: four lots for 15, 408 vials of ceftriaxone for injection USP, 250 mg, single-use vial, packaged in 1-count vials per box and 10-count vials per box; two lots for 7,908 vials of ceftriaxone for injection USP, 500 mg, single-use vial, packaged in 1-count vials per box and 10-count vials per box; six lots for 30,586 vials of ceftriaxone for injection USP, 1 g, single-use vial packaged in 10-count vials per box; and 1 lot for 570 vials for ceftriaxone for injection USP, 2 g, single-use vial packaged in 10-count vials per box.

The company also is voluntarily recalling 741.171 kg of the ceftriaxone sodium (sterile) USP API in nine lots due to the intermediates failing specifications. The API was manufactured by Lupin Limitted.

Source: US Food and Drug Administration

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