Why it was recalled
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Product description
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
Lot numbers, UPCs & expiration codes
Lot #: 18029979, Exp 1/2021
Where it was sold
USA 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-0108-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 23, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 7176 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0108-2021, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86659
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- Lot #: 18029979, Exp 1/2021
- Postal code
- 08816-1145
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0108-2021
- Classification
- Class III
- Recalling firm
- Heritage Pharmaceuticals Inc
- Product quantity
- 7176 bottles
- Termination date
- Jan 28, 2022
- Reason for recall
- Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2020