Zydus Recalls Acyclovir Sodium Injection Due to Crystallization
Zydus Pharmaceuticals is recalling 1,638 packs of Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling 1,638 packs of Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vials. The recall was initiated due to customer complaints regarding crystallization in the finished product. The affected product is packaged in 10 x 10mL Single-Dose Vials per pack and is intended for intravenous infusion only after dilution.
The recalled product is identified by Lot numbers L000126 and L000127, with an expiration date of 12/31/2021. The product was distributed nationwide in the United States. It is manufactured by Cadila Healthcare Ltd. in Vadodara, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ.
Consumers and healthcare providers should stop using the affected product and contact Zydus Pharmaceuticals (USA) Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- ACYCLOVIR (ACYCLOVIR)
- Brand
- ACYCLOVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Injection
- Affected units
- 1,638
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 (3)
- Lot#: L000126
- L000127
- Exp 12/31/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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