Why it was recalled
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Product description
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244
Lot numbers, UPCs & expiration codes
Lot # 07072015LIPO; Exp. 12/15
Where it was sold
TN, AL
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-1832-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2015
- FDA report date
- Oct 7, 2015
- Quantity
- 104 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eagle Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-1832-2015, exactly as published.
Show all FDA fields
- City
- Hoover
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 72101
- Address
- 2200 Riverchase Ctr Ste 675
- Code information
- Lot # 07072015LIPO; Exp. 12/15
- Postal code
- 35244-2918
- Report date
- Oct 7, 2015
- Product type
- Drugs
- Recall number
- D-1832-2015
- Classification
- Class II
- Recalling firm
- Eagle Pharmacy, Inc.
- Product quantity
- 104 vials
- Termination date
- Nov 30, 2015
- Reason for recall
- Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244
- Distribution pattern
- TN, AL
- Recall initiation date
- Aug 28, 2015
- Initial firm notification
- Telephone
- Center classification date
- Sep 29, 2015