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Class I Recall of Antibiotic Injection


January 18, 2019

Reports of grey flecks in vials have prompted a Class I recall of ceftriaxone for injection. According to the January 16, 2019, US Food and Drug Administration (FDA) Enforcement Report, the particulate matter found in the ceftriaxone vials has been identified as shredded rubber from vial stoppers.

Lupin Pharmaceuticals is recalling the following, which were distributed throughout the United States and in Puerto Rico:

  • 250-mg single-use vials, packaged separately (NDC 68180-611-01), from lot C600142 (Exp. 8/19);
  • 250-mg single-use vials, packaged in boxes of 10 (NDC 68180-611-10), from lots C600136 (Exp. 8/19), C600182 (Exp. 9/19), C700147 (Exp. 5/20), C700207 (Exp. 9/20), and C600142, C700147, and C700207 (no expiration dates provided);
  • 500-mg single-use vials, packaged separately (NDC 68180-622-01), from lots C600173 (Exp. 8/19) and C600218 (Exp. 9/19);
  • 500-mg single-use vials, packaged in boxes of 10 (NDC 68180-622-10), from lots C600126, C600127, C600137, and C600143 (Exp. 8/19), C600219 (Exp. 9/19), C700146 (Exp. 5/20), and C700208 and C700209 (Exp. 9/20);
  • 1-g single-use vials, packaged separately (NDC 68180-633-01), from lots C600110 (Exp. 5/19), C600130 (Exp. 8/19), C700113 (Exp. 3/20), and C700143 (Exp. 5/20);
  • 1-g single-use vials, packaged in boxes of 10 (NDC 68180-633-10), from lots C600106 and C600108 (Exp. 5/19), C600128 and C600138 (Exp. 8/19), C600174, C600179, C600180, and C600181 (Exp. 9/19), C700108, C700109, C700110, C700111, and C700112 (Exp. 3/20), C700129, C700130, C700131, C700132, C700138, C700142, and C700145 (Exp. 5/20); and
  • 2-g single-use vials, packaged in boxes of 10 (the FDA lists both NDC 68180-644-01 and NDC 68180-644-10), from lots C600109 (Exp. 5/19), and C600129 and C600135 (Exp 8/19).

Lupin Pharmaceuticals initiated the voluntary recall December 20, 2018. The FDA designated the recall Class I—which warns use of the affected vials could cause serious health problems or death—January 14, 2019.

Ceftriaxone for injection is a prescription antibiotic used to treat a slate of bacterial infections.

Jolynn Tumolo


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