Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Product description
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Lot numbers, UPCs & expiration codes
Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14
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-1391-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 12, 2014
- FDA report date
- Jun 25, 2014
- Quantity
- 550 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- John W Hollis Inc
Original FDA data
Every field from FDA enforcement report D-1391-2014, 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
- Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14
- Postal code
- 37203-2315
- Report date
- Jun 25, 2014
- Product type
- Drugs
- Recall number
- D-1391-2014
- Classification
- Class II
- Recalling firm
- John W Hollis Inc
- Product quantity
- 550 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
- Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, 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