Why it was recalled
Lack of Assurance of Sterility
Product description
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lot numbers, UPCs & expiration codes
Lots: 10/17/18 2976 86561S Exp. 3/16/2019
Where it was sold
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-1028-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 13, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 800 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1028-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82398
- Address
- 9265 Kirby Dr
- Code information
- Lots: 10/17/18 2976 86561S Exp. 3/16/2019
- Postal code
- 77054-2520
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1028-2019
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 800 syringes
- Termination date
- Jan 14, 2020
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2019