DRUG RECALL ALERT
The general public is hereby informed that a recall directive has been issued by NDA to the
Importers/Local Technical Representatives of the manufacturers for the following products.
The public is therefore advised to be vigilant and look out for the recalled products. Information
relating to the recalled products should be submitted to National Drug Authority at: Email:
[email protected]
Products Recalled as at July - August 2018
| BRAND NAME |
REASON / PROBLEM |
| Diclofenac (Diclomax-75) Injection. Batch 170409, manufactured by Jiangsu Pengyao Pharmaceuticals Co Ltd (China) |
Poor quality (product changed color and developed brown soluble crystals) |
| Furosemide B.P. 10mg/2ml Injection.
Batch 180120, Manufactured by Grand Pharmaceutical (China) Co., Ltd |
Mismatching information on PIL and that on primary and secondary packaging |
| Tetracycline Hydrochloride Ophthalmic Ointment USP 1%. Batch C971, Manufactured by Centaur Pharmaceuticals PVT. Ltd (India) |
Poor quality (Product changed color from yellow to brown) |
Products which were suspended due to severe side effects and poor quality
| PRODUCT NAME |
MANUFACTURER |
STRENGTH |
REASON FOR SUSPENSION |
| Gentamycin Injection |
Anhui Chengshi Manufacture Medicine, Co. Ltd. (China) |
80mg/2ml |
Several safety reports received (reports of characteristic serious adverse events following use of product) |
| Gmycin-80 |
Jiangsu Pengyao Pharmaceuticals Co. (China) |
80mg/2ml |
Several safety reports received (reports of characteristic serious adverse events following use of product) |
| Hydrocortisone Sodium Succinate injection |
Karnataka Antibiotics and Pharmaceuticals Ltd. (India) |
100mg |
Poor quality (complaints on quality and the product continuously failed QC tests) |
| Diclofenac injection |
Jiangsu Pengyao Pharmaceuticals Co. Ltd, (China) |
75mg/3ml |
Poor quality (continued receipt of market complaints on quality) |
Products Recalled as at April - May 2018
| DATE INITIATED |
BRAND NAME |
REASON / PROBLEM |
LTR |
| 05/03/2018 |
K-AlbendazoleL |
Failure to comply with USP specifications for Assay |
Kwality Afro-Asia Ltd |
| 06/03/2018 |
Derma-1 |
Failure to comply with BP specifications for Assay |
Super medic |
| 07/03/2018 |
Needles on 2ml syringes |
Failure to comply with manufacturer's specifications and ISO 7864 on needle point test |
Maisha Medical supplies |
| 19/03/2018 |
Hydrocortisone sodium succinate |
Failure to comply with USP specifications for appearance on reconstitution and pH |
Tata (U) Ltd |
| 21/03/2018 |
Agomol |
Failure to comply with BP specifications for Assay |
Gittoes Pharmaceuticals Ltd |
| 21/03/2018 |
Derma-1 |
Failure to comply with BP specifications for Assay |
Super Medic Ltd |
| 03/04/2018 |
Masculan Gold Anatomic contoured male latex condoms |
Failure to comply with manufacturer's specifications for lubricant quality |
Gama Pharmaceuticals Ltd |
| 03/04/2018 |
Alzol - 400 |
Wrong information leaflet in the product which is misleading |
Rene Industries Ltd |
| 11/04/2018 |
Nulife Latex surgical gloves |
Failure to comply with manufacturer's specifications/ISO 10282 for dimensions test. |
Joint Medical Stores |
| 15/04/2018 |
Masculan Gold (atomic) condoms
Masculan Gold (luxury) condoms
Musculan dotted condoms
musculan sensitive condoms
musculan pink colored ribbed condoms |
Failure to comply with manufaturer's specifications for lubricant quality |
Gama Pharmaceuticals |
| 24/04/2018 |
Hydralazine 20mg/ml inj |
Presence of growth and visible particulate matter in the product |
Shreeji Pharmaceuticals Ltd |
| 24/04/2018 |
Revital Re-use syringes |
Parts of the plunger peel off into the contents of the syringe |
Abacus Pharma (A) Ltd |
| 18/05/2018 |
Sequozole tablets (Vet) |
Illegible labels, and easily erased (dates of manufacturers and expiry dates) |
Eram Uganda |
| 18/05/2018 |
Gentamycin Injection |
Illegible and faint labels on the ampoules |
Astra Pharma (U) Ltd |
| 28/05/2018 |
Vitamin B complex Injection |
Illegible and easily erased labels on the ampoules |
Astra Pharma (U) Ltd |
| 30/05/2018 |
Kam-O mint tablets |
Failure to cmply with specifications for hardness test. |
Kampala Pharmaceuticals Industries Ltd |
Directorate of Product Safety