Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Product description
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Lot numbers, UPCs & expiration codes
lot: 2571, use by 9/23/14
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-1404-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 12, 2014
- FDA report date
- Jun 25, 2014
- Quantity
- 80 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- John W Hollis Inc
Original FDA data
Every field from FDA enforcement report D-1404-2014, 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: 2571, use by 9/23/14
- Postal code
- 37203-2315
- Report date
- Jun 25, 2014
- Product type
- Drugs
- Recall number
- D-1404-2014
- Classification
- Class II
- Recalling firm
- John W Hollis Inc
- Product quantity
- 80 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
- LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, 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