Class II
Terminated
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
- Company
- Avkare Inc.
- Recall Initiated
- November 14, 2019
- Posted
- December 4, 2019
- Recall Number
- D-0525-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 104,797 bottles
- Firm Location
- Pulaski, TN, United States
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution
Nationwide.
Lot / Code Info
Lots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021
More recalls by Avkare Inc.
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski...
Aug 17, 2022 · Class III
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, T...
Jun 23, 2021 · Class III
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478...
Dec 23, 2020 · Class II
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