OCTREOTIDE ACETATE

Generic: OCTREOTIDE ACETATE

Hikma Pharmaceuticals USA Inc.Manufacturer
INTRAVENOUS, SUBCUTANEOUSRoute
OCTREOTIDE ACETATEActive Substance
2005-03-28Original Approval

OCTREOTIDE ACETATE is FDA application ANDA076313, sponsored by WEST-WARD PHARMS INT. 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 II2026-03-17
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx onl

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and

Class II2026-03-17
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx onl

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and

Class II2026-03-17
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx onl

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and

Class II2026-04-24
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and

Class I2022-10-07
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use

Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

Top Reported Reactions

1
DIARRHOEA
250 reports
2
NAUSEA
194 reports
3
FATIGUE
185 reports
4
OFF LABEL USE
162 reports
5
ABDOMINAL PAIN
160 reports
6
DEATH
142 reports
7
PRODUCT USE IN UNAPPROVED INDICATION
135 reports
8
DRUG INEFFECTIVE
118 reports
9
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
118 reports
10
HEADACHE
113 reports