Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Lot numbers, UPCs & expiration codes
NDC 33261-0715-00 Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019
Where it was sold
Product was distributed to Florida
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-0810-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 10, 2018
- FDA report date
- May 23, 2018
- Quantity
- 450 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidarex Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0810-2018, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79835
- Address
- 595 N Smith Ave
- Code information
- NDC 33261-0715-00 Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019
- Postal code
- 92880-6920
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0810-2018
- Classification
- Class III
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Product quantity
- 450 bottles
- Termination date
- Dec 4, 2019
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
- Distribution pattern
- Product was distributed to Florida
- Recall initiation date
- Apr 10, 2018
- Initial firm notification
- Center classification date
- May 15, 2018