Orphenadrine Citrate 100 mg tablet, extended release

Where the pills inside were made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Sandoz Inc. names for other drugs.

Repackaging site

• RedPharm Drug, Eden Prairie, MN, United States · repackages it

Recalls

• Mar 21, 2022 · Class II · Sandoz, Inc
  CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
  Lots: Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023
• Jul 11, 2014 · Class III · Sandoz Inc
  Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
  Lots: Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Orphenadrine: every company that makes it

Form

tablet, extended release, oral

Strength

100 mg

Approval

ANDA ANDA040327

On the market since

Feb 15, 2000

Package NDCs

67296-1077-1

Official label

DailyMed (National Library of Medicine), updated Jul 11, 2024

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?