Home / Recalls / Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / D-0135-2017

D-0135-2017 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
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)

Product Description

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

Reason for Recall

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Distribution Pattern

Nationwide

Code Information

Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17

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

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  • D-0861-2022 Class II — Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dos (April 1, 2022)
  • 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-0136-2017 Class III — Clonazepam Tablets, USP, 1.0 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)