DOXYCYCLINE HYCLATE

Generic: DOXYCYCLINE HYCLATE

Lupin PharmaceuticalsManufacturer
ORALRoute
DOXYCYCLINE HYCLATEActive Substance
2017-09-06Original Approval

DOXYCYCLINE HYCLATE is FDA application ANDA207558, sponsored by NOVEL LABS INC. 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 II2020-05-13
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 014

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life

Class II2022-04-13
Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma

cGMP deviations: Temperature abuse

Class II2018-07-24
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. E

Failed Dissolution Specifications:

Class II2018-07-24
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Ea

Failed Dissolution Specifications:

Class II2018-08-01
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: A

Failed Dissolution Specifications: Out of specification result for the dissolution test.

Class II2018-07-30
Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceutic

Failed Dissolution Specifications

Class II2020-05-22
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit do

Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life

Class II2020-05-19
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packa

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time p

Top Reported Reactions

1
DRUG INEFFECTIVE
5,256 reports
2
NAUSEA
4,990 reports
3
OFF LABEL USE
4,773 reports
4
FATIGUE
4,681 reports
5
RASH
4,154 reports
6
DYSPNOEA
4,040 reports
7
DIARRHOEA
4,025 reports
8
PAIN
3,982 reports
9
HEADACHE
3,899 reports
10
VOMITING
3,843 reports