Progest Cream Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Progest 200 mg/1 mL Cream due to inspection findings regarding sterility and stability data.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the quality control issues present a risk to sterility and quality assurance, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Progest 200 mg/1 mL Cream. The recall was initiated following recent inspection observations related to certain quality control procedures.
The FDA identified that the lack of assurance of sterility and stability data does not support the product's expiry date. These quality control issues present a risk to the sterility and quality assurance of the medication.
The recall affects all lots of the product distributed in North Carolina. Consumers who possess this product should contact Health Innovations Pharmacy at (910) 246-5155 for further instructions.
The recalled product
- Product
- Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Topical Steroid
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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, Inc 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.
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