Why it was recalled
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Product description
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to two facilities in CA and NY.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0798-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 11, 2019
- FDA report date
- Jan 29, 2020
- Quantity
- 4,486 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0798-2020, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 84696
- Address
- 625 Kolter Dr Ste 4
- Code information
- 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
- Postal code
- 15701-3571
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0798-2020
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 4,486 tablets
- Termination date
- Jul 23, 2020
- Reason for recall
- CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
- Distribution pattern
- Product was distributed to two facilities in CA and NY.
- Recall initiation date
- Dec 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2020