Why it was recalled
Subpotent Drug: Out of specification for assay (stability testing)
Product description
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
Lot numbers, UPCs & expiration codes
Lot #: 0114588, Exp 10/18
Where it was sold
U.S.A. 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-0338-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 29, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- 24120 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-0338-2018, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 79060
- Address
- 7101 Weddington Rd Nw
- Code information
- Lot #: 0114588, Exp 10/18
- Postal code
- 28027-3412
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0338-2018
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 24120 cups
- Termination date
- Nov 24, 2020
- Reason for recall
- Subpotent Drug: Out of specification for assay (stability testing)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jan 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2018