Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg & 100mg Hard Capsules, EL(24)A/33 |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Glenmark Pharmaceuticals Europe Ltd is recalling various batches of Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg & 100mg Hard Capsules after retesting showed out of specification results. The batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.
Glenmark Pharmaceuticals Europe Ltd
- Atomoxetine 10 mg Hard Capsules, PL 25258/0270 (Batch nos. 1201584, 1203056, 1203859, 1205342, 1205816, 1208831, 1208832, 1211181, 1211187, 1302767, 1302768, 1307838, 1307883, 1307884, 1310439, 1311234)
- Atomoxetine 18 mg Hard Capsules, PL 25258/0271 (Batch Nos. 1207734, 1207741, 1208833, 1302771, 1307741, 1400621, 1400622)
- Atomoxetine 25 mg Hard Capsules, PL 25258/0272 (Batch Nos. 1201599, 1203920, 1208834, 1211263, 1302773, 1308796)
- Atomoxetine 40 mg Hard Capsules, PL 25258/0273 (Batch Nos. 1201647, 1205403, 1211316)
- Atomoxetine 60 mg Hard Capsules, PL 25258/0274 (Batch Nos. 1208837, 1211733, 1308188)
- Atomoxetine 80 mg Hard Capsules, PL 25258/0275 (Batch Nos. 1205406, 1309733)
- Atomoxetine 100 mg Hard Capsules, PL 25258/0276 (Batch Nos. 1211509, 1309825)
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-atomoxetine-10mg-18mg-25mg-10mg-40mg-60mg-80mg-and-100mg-hard-capsules-el-24-a-slash-33
In Hong Kong, Atama Capsules 10mg (HK-66751), Atama Capsules 18mg (HK-66752), Atama Capsules 25mg (HK-66753) and Atama Capsules 40mg (HK-66754) are pharmaceutical products registered by I&C (Hong Kong) Limited (I&C). The products are prescription-only medicines. As confirmed by I&C, the above affected batches have not been imported into Hong Kong. Related news was previously issued by the MHRA, and was posted on the Drug Office website on 6 Jun 2024 and 3 Jul 2024.
On 26 Jul 2024, the Department of Health endorsed I&C to recall one batches of Atama Capsules 10mg (HK-66751) (batch number: 1300360) from the market as a precautionary measure due to potential quality issue of the product. A recall statement was issued on the same day.
Ends/ Wednesday, July 31, 2024
Issued at HKT 13:00
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