Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 0…
- Recall date
- September 12, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0103-2019
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
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