Why it was recalled
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Product description
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
Lot numbers, UPCs & expiration codes
UI1519001-A UI1519002-A UI1519003-A UI1519004-A
Where it was sold
nationwide
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-0529-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 6, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- 19320 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0529-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 84218
- Address
- 279 Princeton Hightstown Rd
- Code information
- UI1519001-A UI1519002-A UI1519003-A UI1519004-A
- Postal code
- 08520-1401
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0529-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 19320 bottles
- Reason for recall
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
- Distribution pattern
- nationwide
- Recall initiation date
- Nov 6, 2019
- Initial firm notification
- Press Release
- Center classification date
- Nov 26, 2019