Mylan Recalls Mirtazapine Tablets Due to Foreign Glipizide Contamination
Mylan Pharmaceuticals is recalling Mirtazapine tablets because bottles may contain foreign Glipizide 10 mg tablets. Consumers should stop using the product and contact their pharmacist.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe rating under the rubric. The hazard involves the presence of a different medication (Glipizide) in a Mirtazapine bottle, posing a risk of incorrect dosing or adverse drug interactions.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Mirtazapine Tablets, USP 45 mg, in 30, 100, and 500-count bottles. The recall is due to the presence of foreign tablets or capsules, specifically the possibility that Glipizide 10 mg tablets are present in the bottles.
The affected product is a prescription-only medication distributed nationwide. The recall involves 37,445 bottles with specific lot numbers and expiration dates of August 2019. The NDC codes for the affected products are 0378-3545-93, 0378-3545-01, and 0378-3545-05.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement. Mylan Pharmaceuticals is the recalling firm for this action.
The recalled product
- Product
- MIRTAZAPINE (MIRTAZAPINE)
- Brand
- MIRTAZAPINE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 37,445
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 (4)
- a) 3078937 and 3078938 (NDC 0378-3545-93)
- exp August 2019 b) 3078937 (NDC 0378-3545-01)
- exp August 2019 c) 3078936 (0378-3545-05)
- exp August 2019
UPCs (2)
- 0303783545936
- 0303783530932
Distribution
Distributed nationwide across the United States.
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