Bisphosphonate Injection Recalled

Dr. Reddy's Laboratories Inc. is recalling zoledronic acid injection, 5 mg/100 mL (0.05 mg/mL), 100-ml single-dose bottle (NDC 43598-331-11 and NDC 55111-688-52), according to the October 3, 2018, US Food and Drug Administration (FDA) Enforcement Report. An impurity was discovered in a tested sample.

The recall spans nearly 70,000 vials from the following batches: BS704 (Exp. 12/18), BS725 (Exp. 6/19), BS745 (Exp. 11/19), BS633 (Exp. 9/18), BS701, BS702, and BS703 (Exp. 12/18), BS708, BS709, BS711, BS712, BS713, BS714, and BS715 (Exp. 3/19), BS726 and BS727 (Exp. 6/19), BS728, BS729, and BS730 (Exp. 7/19), and BS801 (Exp. 3/20). The vials were shipped to retailers, distributors, physician offices, and medical facilities throughout the United States.

Dr. Reddy's Laboratories voluntarily initiated the recall September 12, 2018. The FDA had not issued a recall classification at the time of the recall report.

Zoledronic acid is a prescription injection used to treat high blood calcium levels, osteoporosis, and bone damage associated with Paget’s disease, multiple myeloma, and cancers that spread to the bone.

—Jolynn Tumolo

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