Home / Recalls / Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / D-0136-2017

D-0136-2017 Class III Terminated

Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) — Rockford, IL

Recall Details

Product Type
Drugs
Report Date
November 16, 2016
Initiation Date
September 28, 2016
Termination Date
August 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,472 unit dose blister cards (10 cards of 10 tablets each)

Product Description

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

Reason for Recall

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.

Distribution Pattern

Nationwide

Code Information

Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17

Other recalls by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

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  • D-1013-2019 Class II — Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: M (January 18, 2019)
  • D-1112-2018 Class III — Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister card (August 14, 2018)
  • D-0822-2018 Class II — Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manuf (May 1, 2018)
  • D-0823-2018 Class II — Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manuf (May 1, 2018)
  • D-0622-2017 Class II — Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per (March 21, 2017)
  • D-0493-2017 Class II — Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured (January 27, 2017)
  • D-0135-2017 Class III — Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x (September 28, 2016)
  • D-0650-2016 Class III — Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Myla (January 28, 2016)