Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc....

FDA Drug Recall #D-0164-2016 — Class II — August 24, 2015

Recall Summary

Recall Number D-0164-2016
Classification Class II — Moderate risk
Date Initiated August 24, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm C. O. Truxton
Location Bellmawr, NJ
Product Type Drugs
Quantity 287 bottles

Product Description

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) NDC 24658-312-05 (side panel)

Reason for Recall

Labeling: Wrong Bar Code

Distribution Pattern

Nationwide

Lot / Code Information

Lot # 13D0011FP8, Exp 09/15

Other Recalls from C. O. Truxton

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D-1111-2017 Class I Phenobarbital Tablets USP, 15 mg, 1000 count bo... Apr 20, 2017
D-1116-2017 Class II Phenobarbital Tablets USP, 15 mg, 1000 count bo... Apr 20, 2017
D-1115-2017 Class II Amitriptyline HCL Tablets, USP 50 mg, 100 coun... Apr 20, 2017
D-1113-2017 Class II Phenobarbital Tablets USP, 60 mg, 1000 count bo... Apr 20, 2017

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.