Medicine recalls
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| The United States: International Laboratories, LLC issues voluntary nationwide recall of one (1) lot of Pravastatin Sodium Tablets USP, 40mg packaged in bottles of 30 tablets due to mislabeling |
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The US Food and Drug Administration (FDA) announces that International Laboratories, LLC is voluntarily recalling one (1) lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets (NDC code: 54458-925-16; Lot number: 115698A), to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets.
If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. These are typically minor and reversible issues. However, individuals with epilepsy are at higher risk of seizure on bupropion due to it lowering the seizure threshold. Also, people on MAOIs can have a risky drug interaction with bupropion (hypertensive crisis). Finally, allergic reactions are also possible and could be life threatening.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm571019.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Aug 11, 2017
Issued at HKT 14:00
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