Reported Oct 3, 2018 · Terminated
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only
- Mfd ByGland Pharma Limited D.P
- Pally - 500 043 IndiaMfd
- ForDr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
- Lot codes and dates
- Batch Numbers
BS633EXP 9/2018BS701BS702BS703EXP 12/2018BS708BS709BS711BS712BS713BS714BS715EXP 3/2019BS726BS727EXP 6/2019BS728BS729BS730EXP 7/2019BS801EXP 03/2020
- Batch Numbers
- Amount recalled
- 59,468 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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