Progesterone 200 mg compounded tablets recalled for embedded metal fragments
Coast Quality Pharmacy is recalling Progesterone 200 mg compounded sublingual tablets nationwide due to discovery of broken metal pieces embedded in tablets. Patients should contact their healthcare provider.
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: FDA Class II compounded drug recall with confirmed foreign substance hazard (broken metal fragment embedded in tablets) but no reported illnesses or injuries to date.
Plain-English summary
Coast Quality Pharmacy, LLC, operating as Anazao Health, is recalling Progesterone 200 mg compounded sublingual tablets due to the discovery of broken metal pieces embedded within tablets.
The affected product is a 90-count bottle of Progesterone 200 mg sublingual tablets intended to be dissolved one tablet after dinner nightly. The recall affects lot 240312JL-629220 with an expiration date of September 8, 2024, distributed nationwide throughout the United States.
Consumers who have received this medication should not use the affected product. Patients currently taking this medication should contact their healthcare provider immediately to discuss alternative treatment options and to report any symptoms or concerns.
The recalled product
- Product
- Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug
- Affected units
- 9,896
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)
- Product lot: 240312JL-629220
- Exp. 09/08/2024
Distribution
Distributed nationwide across the United States.
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