The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1427-2020·Announced 2020-08-05

MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

MasterPharm LLC is recalling 600 capsules of Progesterone (Modified Release) 150 mg due to a lack of processing controls.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), and the rule states that if the agency's classification is FDA Class I or II, the score must not be lower than 4.

Plain-English summary

MasterPharm LLC is recalling 600 capsules of Progesterone (Modified Release) 150 mg. The product is distributed nationwide in the U.S. The specific lot code is 02-05-2020:07@6, with a best-use date of 8/3/2020.

The recall was initiated because of a lack of processing controls, which means there is a lack of assurance that the product conforms to specifications. This is classified as an FDA Class II recall.

Consumers who have this product should stop using it and contact MasterPharm LLC at (866) 630-5600 for instructions on how to return or dispose of the medication.

The recalled product

Product
Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Manufacturer
MasterPharm LLC
Category
Drug — Prescription Medication
Hazard
Affected units
600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 02-05-2020:07@6
  • BUD 8/3/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 recalled by MasterPharm LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

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