Where it's 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.
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
0185-0022-010185-0022-10- Official label
- DailyMed (National Library of Medicine), updated Mar 22, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?