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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

MasterPharm LLC: Various Compounded Medications Recalled for Lack of Processing Controls

Agency Publication Date: July 29, 2020
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Summary

MasterPharm LLC is recalling approximately 52,240 units of various compounded medications, including hair loss treatments, hormone therapies, and performance medications, due to a lack of processing controls. This defect means there is no assurance that the drugs meet their intended specifications for quality and potency. The recall affects a wide range of products including Minoxidil, Progesterone, Tadalafil, and Sildenafil in various forms like capsules, tablets, and troches (lozenges) distributed nationwide.

Risk

A lack of processing controls can result in medications that are either too weak to be effective or too strong, potentially leading to unexpected side effects or therapeutic failure. While no specific injuries were reported in this notice, improper dosing of hormones or cardiovascular medications poses a moderate risk to patient health.

What You Should Do

  1. Check your medication bottles for the MasterPharm LLC label and match the product name and strength against the affected list, which includes items like Minoxidil/Biotin, Progesterone (50mg-300mg), Tadalafil (3mg-26mg), and Sildenafil (50mg).
  2. Verify the 'Beyond Use Date' (BUD) and lot-specific identifiers on your packaging; affected products have BUD dates ranging from July 5, 2020, to August 30, 2020.
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to determine if your health has been impacted.
  4. Return any unused portion of the recalled medication to the pharmacy where it was dispensed for a refund.
  5. Contact MasterPharm LLC at (866) 630-5600 for further instructions regarding the return process and any product-related questions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint coordinator at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact pharmacy for return and refund information.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Minoxidil/Biotin 1.25mg/5mg Capsule (90 capsules)
Model:
D-1425-2020
Lot Numbers:
03-03-2020:42@13
Date Ranges: BUD 8/30/2020
Product: Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules (90 capsules)
Model:
D-1426-2020
Lot Numbers:
01-16-2020:70@11
01-30-2020:87@9
Date Ranges: BUD 7/14/2020, BUD 7/28/2020
Product: Progesterone (Modified Release) 150 mg Capsule (90 capsules)
Model:
D-1427-2020
Lot Numbers:
02-05-2020:07@6
Date Ranges: BUD 8/3/2020
Product: Progesterone 150 mg Troche (30 troches)
Model:
D-1428-2020
Lot Numbers:
02-06-2020:26@15
02-07-2020:18@1
02-12-2020:43@6
Date Ranges: BUD 8/4/2020, BUD 8/5/2020, BUD 8/10/2020
Product: Progesterone 300 mg Troche (30 troches)
Model:
D-1429-2020
Lot Numbers:
02-05-2020:86@14
Date Ranges: BUD 8/3/2020
Product: Progesterone (Rapid-Dissolve) 150 mg Tablet (30 tablets)
Model:
D-1430-2020
Lot Numbers:
02-13-2020:83@8
02-14-2020:64@11
Date Ranges: BUD 8/11/2020, BUD 8/12/2020
Product: Progesterone 200 mg Troche (30 troches)
Model:
D-1431-2020
Lot Numbers:
02-06-2020:24@4
02-06-2020:60@3
02-06-2020:65@2
Date Ranges: BUD 8/4/2020
Product: Progesterone 50 mg Modified Release Capsule (90 capsules)
Model:
D-1432-2020
Lot Numbers:
01-10-2020:97@5
Date Ranges: BUD 7/8/2020
Product: Progesterone Modified Release 100 mg Capsule (90 capsules)
Model:
D-1433-2020
Lot Numbers:
02-12-2020:13@5
Date Ranges: BUD 8/10/2020
Product: Progesterone Modified Release 200 mg Capsule (90 capsules)
Model:
D-1434-2020
Lot Numbers:
02-05-2020:30@19
Date Ranges: BUD 8/3/2020
Product: Sildenafil 50 mg Troche (30 troches)
Model:
D-1435-2020
Lot Numbers:
02-04-2020:33@13
Date Ranges: BUD 8/2/2020
Product: Tadalafil 12 mg Capsule (90 capsules)
Model:
D-1436-2020
Lot Numbers:
01-23-2020:62@14
02-26-2020:56@14
Date Ranges: BUD 7/21/2020, BUD 8/24/2020
Product: Tadalafil 18 mg Capsule (90 capsules)
Model:
D-1437-2020
Lot Numbers:
01-23-2020:33@15
02-07-2020:48@3
02-26-2020:09@15
Date Ranges: BUD 7/21/2020, BUD 8/5/2020, BUD 8/24/2020
Product: Tadalafil 26 mg Capsule (90 capsules)
Model:
D-1438-2020
Lot Numbers:
01-27-2020:91@23
02-26-2020:57@16
Date Ranges: BUD 7/25/2020, BUD 8/24/2020
Product: Tadalafil 3 mg Capsule (90 capsules)
Model:
D-1439-2020
Lot Numbers:
01-27-2020:93@21
Date Ranges: BUD 7/25/2020
Product: Tadalafil 7 mg Capsule (90 capsules)
Model:
D-1440-2020
Lot Numbers:
01-08-2020:45@16
01-22-2020:02@19
02-13-2020:05@3
02-24-2020:95@12
Date Ranges: BUD 7/6/2020, BUD 7/20/2020, BUD 8/11/2020, BUD 8/22/2020
Product: Testosterone/Anastrozole Pellet 100/6 mg (100 pellets)
Model:
D-1441-2020
Lot Numbers:
02-10-2020:06@32
Date Ranges: BUD 8/2/2020
Product: Vardenafil 20 mg Troche (30 troches)
Model:
D-1442-2020
Lot Numbers:
01-21-2020:42@8
01-24-2020:59@1
02-04-2020:65@11
Date Ranges: BUD 7/19/2020, BUD 7/22/2020, BUD 8/2/2020
Product: Yohimbine HCL 5.4mg Capsule (90 capsules)
Model:
D-1443-2020
Lot Numbers:
01-20-2020:75@17
Date Ranges: BUD 7/18/2020
Product: Calcium citrate tetrahydrate USP powder (100 gm)
Model:
D-1418-2020
Lot Numbers:
01-23-2020:63@9
Date Ranges: BUD 7/21/2020
Product: D-Biotin 300 mg Capsule (90 capsules)
Model:
D-1419-2020
Lot Numbers:
01-07-2020:12@6
01-23-2020:00@6
Date Ranges: BUD 7/5/2020, BUD 7/21/2020
Product: Estriol 6 mg Capsule (90 capsules)
Model:
D-1420-2020
Lot Numbers:
01-23-2020:03@5
Date Ranges: BUD 7/21/2020
Product: Estriol 8 mg Capsule (90 capsules)
Model:
D-1421-2020
Lot Numbers:
01-28-2020:71@3
Date Ranges: BUD 7/26/2020
Product: Finasteride Plus 1.25mg Capsule (90 capsules)
Model:
D-1422-2020
Lot Numbers:
01-07-2020:64@5
01-13-2020:12@26
01-30-2020:39@8
02-14-2020:10@8
Date Ranges: BUD 7/5/2020, BUD 7/11/2020, BUD 7/28/2020, BUD 8/12/2020
Product: Formula 82F (Minoxidil/Tretinoin/Fluocinolone/Finasteride) (15 mL)
Model:
D-1423-2020
Lot Numbers:
01-15-2020:70@3
01-09-2020:48@2
01-20-2020:79@11
01-23-2020:55@11
01-29-2020:18@1
02-03-2020:89@8
Date Ranges: BUD 7/7/2020, BUD 7/18/2020, BUD 7/26/2020
Product: Formula 82M (Minoxidil/Tretinoin/Fluocinolone) (15 mL / 60 mL)
Model:
D-1424-2020
Lot Numbers:
01-17-2020:45@4
01-13-2020:40@27
01-21-2020:43@11
01-28-2020:88@15
01-31-2020:73@6
02-12-2020:43@16
02-17-2020:86@5
02-21-2020:23@1
Date Ranges: BUD 7/7/2020, BUD 7/18/2020, BUD 7/26/2020, BUD 8/10/2020, BUD 8/16/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85992
Status: Resolved
Manufacturer: MasterPharm LLC
Sold By: MasterPharm; Pharmacies
Manufactured In: United States
Units Affected: 26 products (24 grams; 390 capsules; 90 capsules; 300 capsules; 29580 capsules; 462 units; 543 units; 300 capsules; 1200 capsules; 600 capsules; 330 troches; 90 trouches; 288 tablets; 300 troches; 300 capsules; 600 capsules; 900 capsules; 80 troches; 600 capsules; 900 capsules; 900 capsules; 900 capsules; 12000 capsules; 339 pellets; 134 troches; 90 capsules)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.