July 2014 FDA Recall Orphenadrine Citrate by Sandoz Inc
D-1445-2014 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Sandoz Inc on July 11, 2014 for the product Orphenadrine Citrate. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1445-2014
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
07-11-2014
07-30-2014
781,000 extended release tablets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Batch or Lot Expiration Information
Lot# DM1316; Exp. 05/16
Lot# DM1318; Exp. 05/16
