Recalls / Class III
Class IIID-1527-2016
Product
Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10
- Affected lot / code info
- Lot #: 0111512; Exp. 08/17
Why it was recalled
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
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
- 3,492 unit cartons of 10 x 10 blister cards
- Distribution pattern
- CO, IL, LA, OH
Timeline
- Recall initiated
- 2016-09-15
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2017-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1527-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.