ACYCLOVIR

Generic: ACYCLOVIR

Avet Pharmaceuticals Inc.Manufacturer
ORALRoute
ACYCLOVIRActive Substance
2020-09-14Original Approval

ACYCLOVIR is FDA application ANDA212173, sponsored by YILING. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-04-25
Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actual

Class III2021-04-21
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 0881

Labeling: Incorrect or Missing Lot and/or Exp Date

Class I2021-02-18
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PR

Crystallization: customer complaints for crystallization in finished product.

Class II2022-12-28
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics P

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

Class II2018-02-09
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15],

Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemi

Class II2013-07-17
Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T

Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile

Class I2021-02-18
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRI

Crystallization: customer complaints for crystallization in finished product.

Class III2017-04-27
Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, N

Presence of Foreign Substance: human hair melded into tablet.

Class II2022-09-26
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate float

Top Reported Reactions

1
FATIGUE
7,609 reports
2
DIARRHOEA
6,849 reports
3
OFF LABEL USE
5,852 reports
4
PNEUMONIA
5,285 reports
5
NAUSEA
5,174 reports
6
DEATH
4,603 reports
7
PYREXIA
4,408 reports
8
DRUG INEFFECTIVE
4,300 reports
9
RASH
3,978 reports
10
DYSPNOEA
3,325 reports