FDA Drug Recalls

Recalls / Class II

Class IID-0164-2016

Product

Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)

Affected lot / code info
Lot # 13D0011FP8, Exp 09/15

Why it was recalled

Labeling: Wrong Bar Code

Recalling firm

Firm
C. O. Truxton
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
136 Harding Ave, N/A, Bellmawr, New Jersey 08031-2412

Distribution

Quantity
287 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-08-24
FDA classified
2015-11-10
Posted by FDA
2015-11-18
Terminated
2016-07-25
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0164-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.