Why it was recalled
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Product description
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.
Lot numbers, UPCs & expiration codes
Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Where it was sold
Nationwide with in the United States
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-1309-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 11, 2019
- FDA report date
- May 29, 2019
- Quantity
- 792 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1309-2019, exactly as published.
Show all FDA fields
- City
- East Hanover
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82820
- Address
- 1 Health Plz
- Code information
- Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
- Postal code
- 07936-1016
- Report date
- May 29, 2019
- Product type
- Drugs
- Recall number
- D-1309-2019
- Classification
- Class I
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 792 cartons
- Termination date
- Nov 28, 2023
- Reason for recall
- Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.
- Distribution pattern
- Nationwide with in the United States
- Recall initiation date
- May 11, 2019
- Initial firm notification
- Press Release
- Center classification date
- May 29, 2019