Why it was recalled
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Product description
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
Lot numbers, UPCs & expiration codes
Lot #: 1220019289, Exp 08/21/2020.
Where it was sold
Nationwide within the U.S.
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-1551-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 29, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 366 Containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1551-2020, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 86193
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1220019289, Exp 08/21/2020.
- Postal code
- 06095-1024
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1551-2020
- Classification
- Class I
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 366 Containers
- Termination date
- May 21, 2021
- Reason for recall
- Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
- Distribution pattern
- Nationwide within the U.S.
- Recall initiation date
- Jul 29, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2020