Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

FDA Drug Recall #D-1191-2020 — Class II — April 6, 2020

Recall Summary

Recall Number D-1191-2020
Classification Class II — Moderate risk
Date Initiated April 6, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm The Medicine Shoppe Pharmacy
Location Port Charlotte, FL
Product Type Drugs
Quantity 3 bottles

Product Description

Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Reason for Recall

Lack of Processing Control

Distribution Pattern

Florida

Lot / Code Information

Lot: 45106 Discard by: 8/16/2020; 45128 Discard by: 8/25/2020; 45227 Discard by: 9/14/2020

Other Recalls from The Medicine Shoppe Pharmacy

Recall # Classification Product Date
D-1217-2020 Class II Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/... Apr 6, 2020
D-1177-2020 Class II Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx,... Apr 6, 2020
D-1205-2020 Class II Paregoric Compound (contains Morphine) Solution... Apr 6, 2020
D-1201-2020 Class II Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL ... Apr 6, 2020
D-1220-2020 Class II Paregoric Alternate Elixir 300 mL bottle, Rx, T... Apr 6, 2020

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.