Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Product description
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Lot numbers, UPCs & expiration codes
a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14
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-1399-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 12, 2014
- FDA report date
- Jun 25, 2014
- Quantity
- 45 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- John W Hollis Inc
Original FDA data
Every field from FDA enforcement report D-1399-2014, exactly as published.
Show all FDA fields
- City
- Nashville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 68557
- Address
- 110 20th Ave N
- Code information
- a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14
- Postal code
- 37203-2315
- Report date
- Jun 25, 2014
- Product type
- Drugs
- Recall number
- D-1399-2014
- Classification
- Class II
- Recalling firm
- John W Hollis Inc
- Product quantity
- 45 mL
- Termination date
- Jul 2, 2014
- Reason for recall
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Distribution pattern
- Nationwide
- Recall initiation date
- May 12, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jun 18, 2014