FDAFDA · Food and drugs·Recall number D-0644-2020
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
Published January 15, 2020 · Recall initiated: December 17, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Natiowide
- Lot
- 7701034A 7701057A 7701058A 7701059A 7701060A 7701061A 7701071A 7701072A 7701073A 7701074A 7701105A 7701106A 7701107A 7701108A 7701109A 7701113A 7701114A 7701115A 7701116A 7701121A 7701122A 7701123A 7701124A 7701125A 7701126A 7701151A 7701152A 7701165A 7701154A 7701155A 7701163A 7701176A 7701190A 7701221A 7701222A 7701223A 7701224A 7701225A 7701235A 7701253A 7701254A 7701255A 7701256A 7701257A 7701258A 7701259A 7701266A 7701267A 7701268A 7701273A 7701275A 7701276A 7701277A 7701294A 7701295A 7701296A 7701297A 7701300A 7701301A 7701302A 7701303A 7701304A 7701306A 7701307A 7701308A 7701309A 7701310A 7701311A 7701312A 7701313A 7701314A 7701315A 7701316A 7701328A 7701329A 7701330A 7701331A 7701332A 7701333A 7701344A 7701153A 7701175A 7701234A 7701274A 7701305A 7701345A 7701352A 7701353A 7701354A 7701355A 7701356A 7701382A 7701383A 7701384A 7701385A 7701402A 7701403A 7701404A 7701405A 7701419A 7701420A 7701422A 7701423A 7701424A 7701425A 7701426A 7701427A 7701430A 7701432A 7701433A 7701448A 7701449A 7701450A 7701451A 7701454A 7701455A 7701471B 7701557A 7701558A 7701559A 7701583A 7701584A 7701585A 7701586A 7701587A 7701588A 7701614A 7701615A 7701616A 7701621A 7701637A 7701638A 7701639A 7701652A 7701653A 7701654A 7701655A 7701656A 7701657A 7701658A 7701664A 7701665A 7701666A 7701667A 7701668A 7701669A 7701670A 7701680A 7701613A 7701699A 7701700A 7701701A 7701714A 7701715A 7701716A 7701717A 7701718A 7701719A 7701720A 7701721A 7701781A 7701782A 7701783A 7701784A 7701796A 7701926A 7701927A 7701937A 7701938A 7701939A 7701940A 7701941A 7702004A 7702005A 7702006A 7702007A 7702008A 7702009A 7702010A 7702011A 7702013A 7702014A 7702068A 7702222A 7702223A 7702224A 7702230A 7702231A 7702232A 7702233A 7702242B 7702243A 7702244A 7702245A 7702246A 7702247A 7702248A 7702249A 7702250A 7702251A 7702252A 7702291A 7702292A 7702293A 7702302A 7702303A 7702304A 7702305A 7702306A 7702307A 7702308A 7702309A 7702331A 7702332A 7702333A 7702334A 7702339A 7702340A 7702346A 7702353A 7702354A 7702355A 7702356A 7702376A 7702377A 7702378A 7702379A 7702390A 7702310A 7702411A 7702412A 7702490A 7702493A 7702494A 7702498A 7702499A 7702500A 7702501A 7702502A 7702503A 7702516A 7702517A 7702518A 7702519A 7702549A 7702550A 7702551A 7702552A 7702601A 7702602A 7702603A 7702604A 7702605A 7702606A 7702607A 7702608A 7702621A 7702622A 7702623A 7702655A 7702656A 7702657A 7702658A 7702741A 7702742A 7702743A 7702765A 7702766A 7702777A 7702778A 7702779A 7702780A 7702781A 7702782A 7702783A 7702784A 7702794A 7702795A 7702796A 7702797A 7702811A 7702812A 7702813A 7702814A 7702815A 7702816A 7702817A 7702818A 7702819A 7702820A 7702821A 7702822A 7702848A 7702849A 7702850A 7702856A 7702857A 7702861A 7702896A 7702897A 7702898A 7702899A 7702910A 7702911A 7702912A 7702913A 7702914A 7702915A 7702916A 7702924A 7702925A 7702926A 7702927A 7703060A 7703061A 7703062A 7703063A 7703064A 7703065A 7703066A 7703067A 7703068A 7703144A 7703145A 7703146A 7703147A 7703174A 7703175A 7703176A 7703177A 7703178A 7703179A 7703180A 7703181A 7703182A 7703183A 7703191A 7703192A 7703193A 7703194A 7703195A 7703236A 7703237A 7703238A 7703239A 7703240A 7703248A 7703249A 7703250A 7703251A 7703252A 7703253A 7703254A 7703255A 7703283A 7703284A 7703290A 7703291A 7703292A 7703293A 7703294A 7703295A 7703296A 7703318A 7703330A 7703331A 7703332A 7703333A 7703334A 7703347A 7703348A 7703349A 7703350A 7703351A 7703394A 7703395A 7703409A 7703491A 7703492A 7703493A 7703494A 7703495A 7703496A 7703497A 7703498A 7703499A 7703500A 7703501A 7703502A 7703503A 7703504A 7703635A 7703636A 7703637A 7703638A 7703775A 7703776A 7703777A 7703778A 7703779A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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