Exact FDA event identifier

Event 69233

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 11, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Qualitest Pharmaceuticals

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

D-1605-2014

Recall number: D-1605-2014
Initiated: September 11, 2014
Classification: Class III
Status: Terminated
Recalling firm: Qualitest Pharmaceuticals
Quantity: 159,913 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; 6 month stability time point

Code information

100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015

Distribution pattern

Nationwide