PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS US...

FDA Drug Recall #D-222-2013 — Class II — February 20, 2012

Recall Summary

Recall Number D-222-2013
Classification Class II — Moderate risk
Date Initiated February 20, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Physicians Total Care, Inc.
Location Tulsa, OK
Product Type Drugs
Quantity 3660 capsules

Product Description

PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09

Reason for Recall

Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.

Distribution Pattern

FL, NC, TX, CO, VA, SC, GA, KS, LA, MO

Lot / Code Information

5YLZ EXP 04/13, 5ZCE EXP 04/13, 61TX EXP 04/13, 65YD EXP 07/13, 6COJ EXP 09/13, 4ZT6 EXP 02/12, 58HD EXP 02/12, 5G4L EXP 08/12, 5KBU EXP 10/12, 5M3W EXP 10/12, 5OHI EXP 10/12, 6JHL EXP 01/14, 6HJQ EXP 01/14

Other Recalls from Physicians Total Care, Inc.

Recall # Classification Product Date
D-0237-2015 Class II CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20... Sep 22, 2014
D-390-2014 Class II Carisoprodol IV ( Carisoprodol Tablets USP) 350... Nov 22, 2013
D-0239-2015 Class III Loratadine 24 HR-OTC,10 mg, 30-count bottle, Ma... Sep 11, 2013
D-826-2013 Class II Belladonna Alkaloids/PB (Belladonna Alkaloids /... Jun 17, 2013
D-499-2013 Class III Camila 0.35 mg Tablets, 6 cards of 28 pills, Di... Mar 18, 2013

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.