Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Product description
Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Lot numbers, UPCs & expiration codes
Lot Number: 07202014@5, Exp 9/15/2014; 07152014@1, Exp 9/30/2014
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-0154-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 27, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 110 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Martin Avenue Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-0154-2015, exactly as published.
Show all FDA fields
- City
- Naperville
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69152
- Address
- 1247 Rickert Dr
- Code information
- Lot Number: 07202014@5, Exp 9/15/2014; 07152014@1, Exp 9/30/2014
- Postal code
- 60540-1008
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0154-2015
- Classification
- Class II
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Product quantity
- 110 mL
- Termination date
- May 31, 2018
- Reason for recall
- Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 27, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 29, 2014