Why it was recalled
Non-Sterility
Product description
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Lot numbers, UPCs & expiration codes
Lot: 01052018@46 Use By: 2/9/2018
Where it was sold
TN, SC
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-0600-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 12, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 5 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Compounding Pharmacy of America
Original FDA data
Every field from FDA enforcement report D-0600-2018, exactly as published.
Show all FDA fields
- City
- Knoxville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 79168
- Address
- 6216 Highland Place Way Ste 101-A
- Code information
- Lot: 01052018@46 Use By: 2/9/2018
- Postal code
- 37919-4068
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0600-2018
- Classification
- Class I
- Recalling firm
- The Compounding Pharmacy of America
- Product quantity
- 5 vials
- Termination date
- Feb 10, 2021
- Reason for recall
- Non-Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
- Distribution pattern
- TN, SC
- Recall initiation date
- Jan 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2018