Class II · Moderate risk
Orphenadrine Citrate Extended-Release Tablets
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Orphenadrine Citrate Extended Release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Affected NDCs
0185-0022-01
0185-0022-10
Compare with the code on your package — it is the most precise check available.
Drug: Orphenadrine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Orphenadrine Citrate NDC 00185-0022 |
100 mg/1 | Tablet, Extended Release Oral |
Sandoz Inc | Rx |
- Recalling firm
- Sandoz Inc
- NDC code
- 0185-0022-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1445-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Orphenadrine recalls
See all
Class II · Moderate risk
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Orphenadrine Citrate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
ORPHENADRINE CITRATE ER Tablet
Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.
Other recalls by Sandoz Inc
All 2014 recalls
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class I · High risk
Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
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