Home / Recalls / Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / D-0823-2018

D-0823-2018 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
May 30, 2018
Initiation Date
May 1, 2018
Termination Date
March 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,152 blister cards of 100 capsules each

Product Description

Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.

Reason for Recall

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #: 3092310, Exp. 03/2019

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

  • D-0860-2022 Class II — Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dos (April 1, 2022)
  • 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-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-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)