POLYMYXIN B SULFATE AND TRIMETHOPRIM
Generic: POLYMYXIN B SULFATE AND TRIMETHOPRIM
Sandoz IncManufacturer
OPHTHALMICRoute
POLYMYXIN B SULFATEActive Substance
1998-04-13Original Approval
POLYMYXIN B SULFATE AND TRIMETHOPRIM is FDA application ANDA064211, sponsored by SANDOZ. 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 I2022-01-26
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, DPresence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class III2019-10-17
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured bLabeling: Incorrect or missing package insert.
Class II2022-04-13
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-cGMP deviations: Temperature abuse
Top Reported Reactions
1
DRUG INEFFECTIVE
376 reports
2
PAIN
312 reports
3
DRUG HYPERSENSITIVITY
271 reports
4
PNEUMONIA
243 reports
5
MALAISE
242 reports
6
VOMITING
223 reports
7
DYSPNOEA
200 reports
8
OEDEMA
195 reports
9
CHEST PAIN
194 reports
10
ASTHMA
193 reports