CLASS II Drug recall · Reported 3 Jul 2024 · FDA Enforcement Report
Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy
Coast Quality Pharmacy is recalling Progesterone 200 mg, Compounded, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, distributed nationwide in the US. The recall was initiated on 24 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0563-2024
- FDA event ID
- 94691
- Recalling firm
- Coast Quality Pharmacy, Tampa, FL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 24 Apr 2024
- FDA classified
- 22 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Drug class
- Hormones & Birth Control
Timeline
| 24 Apr 2024 | Recall initiated by company | |
| 22 Jun 2024 | Classified by FDA | +59 days |
| 3 Jul 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Which lots are affected?
Product lot: 240312JL-629220; Exp. 09/08/2024
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Coast Quality Pharmacy
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine HCL and Baclofen and Fentanyl Citrate recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Fentanyl Citrate in all strengths, all doses recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF recalled | Coast Quality Pharmacy | Other | Nationwide |
| Drug | CLASS II | Hydromorphone HCL and Clonidine HCL in all strengths recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Clonidine HCL and Baclofen in all strengths, all doses recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
Other Progesterone recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone Injection, USP, 500 mg per (50mg/mL) Multiple-Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone 100mg/ML Inj # Ethyl Oleate Injectable recalled | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Progesterone 100mg/ML Mdv Oil Injection recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Progesterone Capsules, 200 mg recalled by Dr. Reddy's LaboratoriesProgesterone | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |