Why it was recalled
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Product description
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Lot numbers, UPCs & expiration codes
Lot # 20230323-728BF8, exp. 08/20/2023
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-0778-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 22, 2023
- FDA report date
- Jun 7, 2023
- Quantity
- 198
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
Original FDA data
Every field from FDA enforcement report D-0778-2023, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 92374
- Address
- 4 Constitution Way Ste L
- Code information
- Lot # 20230323-728BF8, exp. 08/20/2023
- Postal code
- 01801-1042
- Report date
- Jun 7, 2023
- Product type
- Drugs
- Recall number
- D-0778-2023
- Classification
- Class III
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Product quantity
- 198
- Termination date
- Jul 25, 2023
- Reason for recall
- Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 22, 2023
- Initial firm notification
- Center classification date
- Jun 1, 2023