The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0784-2016·Announced 2016-04-06

Dr. Reddy's Recalls Zoledronic Acid Injection Due to Sterility Concerns

Dr. Reddy's Laboratories is recalling 3,342 vials of Zoledronic Acid Injection due to defective seals that may compromise sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an intravenous injection, which poses a significant risk of infection or serious injury.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 3,342 vials of Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle. The product is identified by Lot BS523 with an expiration date of 10/2017 and NDC 55111-688-52. The recall was initiated because of a lack of assurance of sterility caused by defective seals where the metal silver ring was not attached tightly to the vial.

The affected product was distributed nationwide. This is a prescription-only medication administered via the intravenous route. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected vials and contact Dr. Reddy's Laboratories for further instructions or a replacement. Consumers should verify the lot number and expiration date on their medication packaging to determine if it is affected.

The recalled product

Product
ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Brand
ZOLEDRONIC ACID
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Injection
Hazard
Affected units
3,342

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot BS523
  • exp 10/2017

UPCs (1)

  • 0355111688525

Distribution

Distributed nationwide across the United States.

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