Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Product description
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
Lot numbers, UPCs & expiration codes
Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .
Where it was sold
Nationwide in the USA
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-0963-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2018
- FDA report date
- Jul 25, 2018
- Quantity
- 10500 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
Original FDA data
Every field from FDA enforcement report D-0963-2018, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 80307
- Address
- 24416 N 19th Ave
- Code information
- Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .
- Postal code
- 85085-1887
- Report date
- Jul 25, 2018
- Product type
- Drugs
- Recall number
- D-0963-2018
- Classification
- Class II
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Product quantity
- 10500 syringes
- Termination date
- Jan 24, 2020
- Reason for recall
- Lack of Assurance of Sterility: Potential leakage of bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2018