Key Takeaway

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10 by C. O. Truxton was recalled on April 20, 2017. The hazard: Labeling: Label Mixup; potentially mislabeled

FDA Drug Class II Terminated

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

Recalled: April 20, 2017 ~unknown units affected D-1115-2017

Description

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

Hazard / Reason

Labeling: Label Mixup; potentially mislabeled

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

Drugs

Company Information

C. O. Truxton

Bellmawr, NJ, United States

View all 7 recalls by C. O. Truxton →

Distribution

Nationwide

Related Recalls

FDA Drug Class I

Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10

April 20, 2017
FDA Drug Class I

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

April 20, 2017
FDA Drug Class II

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

April 20, 2017
FDA Drug Class II

Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10

April 20, 2017
FDA Drug Class II

Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distr

April 20, 2017
FDA Drug Class II

Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) ND

August 24, 2015

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.