Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot: D24001 Exp. 4/1/22
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Olympia Compounding Pharmacy dba Olympia Pharmacy
Reason for Recall:
Super Potent and Failed Reconstitution Time
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00

Product Codes/Lot Numbers:

Lot: D24001 Exp. 4/1/22

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0724-2022

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