Class II · ModerateRecall completed
Ranitidine Capsules 150 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch # 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021
Where it was soldProduct was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAppco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623
| Distributed by / for | ANI Pharmaceuticals, Inc., Baudette, MN 56623 |
| NDC | 62559-690-60 |
Show the full FDA record
| Full product label | Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. |
| Recalling firm | Appco Pharma LLC |
| Distribution | Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product. |
| Quantity | 624 bottes |
| Recall initiated | 2020-01-07 |
| Report date | 2020-01-15 |
| Recall completed | 2020-04-24 |
| Recall number | D-0649-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Piscataway NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.