Multi-event September 2016 FDA Recall Drug by Mylan Institutional, Inc.
d.b.a. Udl Laboratories
This Multi-event Class III drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on September 28, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0136-2017
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
09-28-2016
11-16-2016
46,472 unit dose blister cards (10 cards of 10 tablets each)
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.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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
08-28-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
Batch or Lot Expiration Information
Lot# : 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17
Recall Number: D-0135-2017
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
09-28-2016
11-16-2016
1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)
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.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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
08-28-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
Batch or Lot Expiration Information
Lot# : a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17
