Ranitidine 150 mg tablet Original Supplier's recall: Nitrosamine Impurity
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Why was Ranitidine 150 mg tablet Original Supplier's recalled?
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: J0376034-052319, exp. date 05/2020 Lot #: J0406133-093019, exp. date 10/2020 Lot #: J038005-082719, exp. date 08/2020 Lot #: J0390280-072519, exp. date 07/2020 Lot #: J0390277-072519, exp. date 07/2020 Lot #: J0349352-012519, exp. date 01/2020
- Product
- Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 4,486 tablets
- Distribution
- Product was distributed to two facilities in CA and NY.
- Recall date
- January 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)