Recalls / Class III
Class IIID-0043-2015
Product
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
- Brand name
- Methylprednisolone
- Generic name
- Methylprednisolone
- Active ingredient
- Methylprednisolone
- Route
- Oral
- NDC
- 68084-149
- FDA application
- ANDA040183
- Affected lot / code info
- AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11
Why it was recalled
Subpotent; 6 month stability time point
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2,005 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-10
- FDA classified
- 2014-10-23
- Posted by FDA
- 2014-10-29
- Terminated
- 2015-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0043-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.