Mylan Recalls Glipizide Extended-Release Tablets Due to Foreign Tablet Presence
Mylan Pharmaceuticals is recalling 1,338 bottles of Glipizide 5 mg Extended-Release Tablets because they may contain 10 mg tablets.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as incorrect medication dosage) are categorized as Severe.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 1,338 bottles of Glipizide Extended-Release Tablets, 5 mg, 1000 count bottles. The recall is due to the presence of foreign tablets, specifically Glipizide 10 mg tablets, which may be found in the bottles intended to contain only 5 mg tablets.
The affected product is identified by Batch # 3074621, with a date of June 2018. The NDC number for the product is 0378-0342-10. The recall is classified as Class II by the FDA.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific batch and NDC number. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,338
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 3074621
- June 2018
Distribution
Distributed nationwide across the United States.
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