FDA Drug Recalls

Recalls / Class II

Class IID-1515-2014

Product

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10

Affected lot / code info
Lot 102492, exp 01/2016

Why it was recalled

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Recalling firm

Firm
Mckesson Packaging Services
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7101 Weddington Rd NW, N/A, Concord, North Carolina 28027-3412

Distribution

Quantity
1240 boxes/124,000 tablets
Distribution pattern
CO & OH

Timeline

Recall initiated
2014-07-30
FDA classified
2014-08-06
Posted by FDA
2014-08-13
Terminated
2017-04-27
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1515-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls