Zydus Recalls Acyclovir Sodium Injection Due to Crystallization
Zydus Pharmaceuticals is recalling 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 FDA classified this recall as Class I, which indicates a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. This classification mandates a severity score of at least 4.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. has initiated a recall of Acyclovir Sodium Injection 1000mg/20mL vials. The product is intended for intravenous infusion and must be diluted prior to use.
The recall was prompted by customer complaints regarding crystallization found in the finished product. The affected items are packaged in 10 x 20mL single-dose vials per pack. Specific lot numbers involved include L000155 (expiration date 12/2021) and L000156 (expiration date 1/2022). A total of 816 packs were distributed nationwide across the USA.
Consumers who possess these specific lots should stop using them immediately. Healthcare providers and patients are advised to contact Zydus Pharmaceuticals for further instructions regarding the return or disposal of the product.
The recalled product
- Product
- ACYCLOVIR (ACYCLOVIR)
- Brand
- ACYCLOVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Intravenous Injection
- Affected units
- 816
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 (4)
- Lot#: L000155
- Exp 12/2021
- L000156
- Exp 1/2022
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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