Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Product description
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
Lot numbers, UPCs & expiration codes
Lots: 8CE1644, 8CE1645, 8DE1401, 8DE1402, 8DE1403, 8DE1769, 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229
Where it was sold
Nationwide USA
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-1015-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 23, 2019
- FDA report date
- Mar 25, 2020
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-1015-2020, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 84127
- Address
- 515 Eastern Ave
- Code information
- Lots: 8CE1644, 8CE1645, 8DE1401, 8DE1402, 8DE1403, 8DE1769, 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229
- Postal code
- 49010-9070
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1015-2020
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Termination date
- Nov 6, 2020
- Reason for recall
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 13, 2020