Promise Pharmacy Recalls Trim Calm Vials Due to Sterility Concerns
Promise Pharmacy is recalling 7 vials of Trim Calm due to a lack of sterility assurance. The product was distributed nationwide in the USA.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable or high-risk compounded drugs are categorized as Severe.
Plain-English summary
Promise Pharmacy, LLC is recalling 7 vials of Trim Calm, a prescription-only compounded medication containing GABA, Magnesium, Taurine, and Theanine. The recall was initiated due to a lack of sterility assurance in the product.
The affected product is identified by Lot 11052018@7 with a beyond-use date of 12/20/2018. The recall covers 10 mL vials distributed nationwide in the USA.
Consumers who possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded Medication
- Hazard
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)
- Lot: 11052018@7 BUD: 12/20/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, 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 51 products in this recall →Related recalls
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