Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Easte...

FDA Drug Recall #D-0650-2018 — Class II — March 22, 2018

Recall Summary

Recall Number D-0650-2018
Classification Class II — Moderate risk
Date Initiated March 22, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Partell Specialty Pharmacy
Location Las Vegas, NV
Product Type Drugs
Quantity five vials

Product Description

Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper,

Reason for Recall

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Distribution Pattern

NV only

Lot / Code Information

Lot#: 20171220@10, BUD 06/18/201; 20171017@83, BUD 04/15/2018; 20171102@40, BUD 05/01/2018; 20180118@97, BUD 07/17/2018; 00180213@32, BUD 08/12/2018.

Other Recalls from Partell Specialty Pharmacy

Recall # Classification Product Date
D-0666-2018 Class II Testosterone 40 mg pellet packaged in amber via... Mar 22, 2018
D-0653-2018 Class II Testosterone/Finasteride 60 mg/5 mg pellet Ambe... Mar 22, 2018
D-0658-2018 Class II TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, ... Mar 22, 2018
D-0652-2018 Class II Testosterone/Estradiol 60 mg/6 mg pellet Amber ... Mar 22, 2018
D-0642-2018 Class II Methionine 25mg/Inositol 50mg/Choline 50mg/ B12... Mar 22, 2018

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

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.