Class II
Terminated
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
- Company
- American Health Packaging
- Recall Initiated
- November 20, 2019
- Posted
- March 18, 2020
- Recall Number
- D-1003-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 53,619 cartons
- Firm Location
- Columbus, OH, United States
Reason for Recall
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Distribution
Nationwide USA
Lot / Code Info
Lot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020
More recalls by American Health Packaging
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count b...
May 25, 2022 · Class III
Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 m...
May 4, 2022 · Class III
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cu...
Mar 16, 2022 · 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