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Safety information

Product recalls

【Update Date:2016-06-15】 unit:品質監督管理組

GMP Alert issued in 2016

Date Brand Name
(Product Description)
Drug Product License NO. Batch number License holder Reason/Problem
2016/06/15 Plusamin Injection "T.F." DOHPM 33700 3150209
4150208
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Taurine B Injection "T.F." DOHPM 33758 3158203
4158206
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Shoren Suppositories 12.5mg "T.F." (Diclofenac) DOHPM 29558 1097203
3097202
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Dicokan Tablets 30mg "T.F." (Dextromethorphan) DOHPM 30694 3073201
5073201
5073202
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Molin Tablets 10mg"T.F."(Domperidone) DOHPM 32834 4116206
5116205
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Famoster F.C. Tablets 20mg "T.F." DOHPM 43935 4213205 TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Toeefon F.C. Tablets 250mg "T.F." (Mefenamic Acid) DOHPM 25223 5077203 TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Urodine F.C. Tablets 100mg DOHPM 26175 4087210
5087201
5087206
5087213
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Clindamycin Capsules 150mg "T.F." DOHPM 33382 5127201 TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/06/15 Lincomycin HCl Injection 300mg/ml "T.F." DOHPM 25595 3360701
5360701
TA FONG PHARMACEUTICAL CO., LTD. Products returned from the market were re-labeled/re-packed in an unauthorized facility.
Data in the batch records, returned product records and destroyed records had been falsified.
2016/05/01 Total Bandi Enema (10 ml) DOHPM 015906 All batches Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 Total Bandi Enema (20 ml) DOHPM 015906 6055
6056
6057A
6057B
6059
6060
6061
6062
6063
Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 POVIDONE-IODINE SOLUTION 10% "T.K." DOHPM 020680 5337
6005
6028
6029
6054
6058
Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable<./td>
2016/05/01 HYDROGEN PEROXIDE SOLUTION "T.K." DOHPM 014141 5306
5337
5358B
Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 BENZALKONIUM CHLORIDE SOLUTION 50% "T.K." DOHPM 030991 4267 Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 TINCTURA IODI "T.K." DOHPM 014142 5345 Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 JYE-JIUNN ETHANOL SOLUTION 75% "T.K."(800 ml) DOHPM 012728 5348 Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable
2016/05/01 JYE-JIUNN ETHANOL SOLUTION 75% "T.K."(500 ml) DOHPM 012728 5364 Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable
2016/05/01 ACOMAZINE CREAM "T.K." DOHPM 032501 6020
6021
6022
6025
6048
Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable
2016/05/01 PI FU HAW CREAM (CETRIMIDE) "TIEN CHIEN" DOHPM 036631 6047 Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 KEH JING HAND SANITIZER SOLUTION DOHPM 012620 5304
5341B
Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.
2016/05/01 KONFORT CREAM 1MG/GM (TRIAMCINOLONE) "T.K." DOHPM 032580 3240 Tien Chen Pharmaceutical Co., Ltd. Drug production and storage didn't comply with GMP.
The batch record was in doubt.
The storage environment was not suitable.

Product Recall Issued in 2015

Date Brand Name
(Product Description)
Drug Product License NO. Batch number License holder Reason/Problem
2015/09/18 Anexat/Lanexat DOHPM 017124 F0119F01
F0119F02
F0119F03
F0119F04
F0119F06
F0119F07
F0119F08
Pfizer Biotech Co. Obsvered impurities in Drug
2015/06/02 SODIUM CHLORIDE INJECTION Y.F. DOHPM 001085 Total 98 batches
(Expiration Date before 2017.4.29)
Y F CHEMICAL CORP., Xinzhuang Plant One lot of the product is being recalled due to potential microbial contamination.
2015/05/18 Spormine Injection "Tai Yu" 20mL DOHPM 015430 All batches
(Expiration Date before 2017 April)
Tai Yu Chemical & Pharmaceutical Co., Ltd. A batch of product was manufactured using API which were not registered by TFDA.