Why it was recalled
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Product description
Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
Lot numbers, UPCs & expiration codes
Lot #: S-60162, BUD 10/12/2019; S-60176, BUD 11/2/2019; S-60187, BUD 11/11/2019; S-60189, BUD 11/16/2019; S-60190, BUD 11/16/2019; S-60222, BUD 01/20/2020
Where it was sold
Healthcare facilities/clinics in AZ and CO
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-0144-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2019
- FDA report date
- Oct 23, 2019
- Quantity
- 1646 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Atlas Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0144-2020, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 83710
- Address
- 711 E Carefree Hwy Ste 107
- Code information
- Lot #: S-60162, BUD 10/12/2019; S-60176, BUD 11/2/2019; S-60187, BUD 11/11/2019; S-60189, BUD 11/16/2019; S-60190, BUD 11/16/2019; S-60222, BUD 01/20/2020
- Postal code
- 85085-0103
- Report date
- Oct 23, 2019
- Product type
- Drugs
- Recall number
- D-0144-2020
- Classification
- Class II
- Recalling firm
- Atlas Pharmaceuticals, LLC
- Product quantity
- 1646 vials
- Termination date
- Jun 3, 2020
- Reason for recall
- Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
- Distribution pattern
- Healthcare facilities/clinics in AZ and CO
- Recall initiation date
- Aug 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2019