Class II
Terminated
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
This recall has been terminated (originally issued March 15, 2017).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- January 19, 2017
- Posted
- March 15, 2017
- Recall Number
- D-0492-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 37,445 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Distribution
Nationwide
Lot / Code Info
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
More recalls by Mylan Pharmaceuticals Inc.
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc....
Mar 26, 2025 · Class II
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 4...
Aug 3, 2022 · Class I
Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multip...
May 4, 2022 · Class I
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026