Apotex Corp., is recalling all pack sizes and formats of Ranitidine Hydrochloride tablets.
The products are contaminated with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.
NDMA is classified as a probable substance that could cause cancer.
The following products are being recalled:
| Product | Strength | Pack Size | NDC Number |
|---|---|---|---|
| Ranitidine tablets, USP 150mg- acid reducer (Rite Aid) | 150 mg | 50's Bottle | 11822-6052-1 |
| Ranitidine tablets, USP 150mg- acid reducer (Rite Aid) | 150 mg | 65's Bottle | 11822-6052-2 |
| Ranitidine tablets, USP 150mg- acid reducer (Rite Aid) | 150 mg | 95's Bottle | 11822-4727-3 |
| Ranitidine tablets, USP 150mg- acid reducer (Walmart) | 150 mg | 65's Bottle | 49035-117-06 |
| Ranitidine tablets, USP 150mg- acid reducer (Walmart) | 150 mg | 24's Bottle | 49035-100-00 |
| Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS) | 150 mg | 200's Bottle | 0363-1030-07 |
| Product | Strength | Pack Size | NDC Number |
|---|---|---|---|
| Ranitidine tablets, USP 150 mg - acid reducer (Rite Aid) | 150 mg | 24's Bottle | 11822-6051-8 |
| Ranitidine tablets, USP 150mg- acid reducer (Walmart) | 150 mg | 130's Bottle | 49035-100-07 |
| Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS) | 150 mg | 24's Bottle | 0363-1013-02 |
| Wal-Zan® 75 RANITIDINE TABLETS, USP 75 mg / ACID REDUCER (WALGREENS) | 75 mg | 30's Bottle | 0363-1029-03 |
| Cool mint Ranitidine tablets, USP 150 mg - acid reducer (Rite Aid) | 150 mg | 24's Bottle | 11822-6107-4 |
| Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS) | 150 mg | 65's Bottle | 0363-1030-06 |
| Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS) | 150 mg | 95's Bottle | 0363-1030-09 |
What to do
Consumers who have experienced any problems that may be related to taking or using this drug product should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the recalled product.
Customers who purchased the recalled products may contact Apotex at (800)706-5575 from 8:30am – 5:00pm (EST) Monday thru Friday) by email at UScustomerservice@Apotex.com.
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