Why it was recalled
Subpotent; 6 month stability time point
Product description
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
Lot numbers, UPCs & expiration codes
AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11
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-0043-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 10, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 2,005 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0043-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 69511
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11
- Postal code
- 43217-1188
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D-0043-2015
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 2,005 cartons
- Termination date
- Jun 1, 2015
- Reason for recall
- Subpotent; 6 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 23, 2014