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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Olympia Pharmacy Compounded Injectable Drugs Recalled for Potency Issues

Agency Publication Date: March 24, 2022
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Summary

Olympia Pharmacy is recalling various compounded injectable medications, including Sermorelin Acetate, NAD+, and B12 injections, due to potency and quality concerns. Approximately 9,984 vials are affected because they were found to be either sub-potent (too weak) or super-potent (too strong), or they failed to dissolve properly within the required time. No injuries or incidents have been reported to date, but the firm initiated this voluntary recall after discovering these quality issues through testing.

Risk

Injectable medications that are too strong or too weak can cause patients to receive the wrong dose, potentially leading to treatment failure or unexpected side effects. Additionally, medication that fails to dissolve properly (exceeds reconstitution time) may not be safe or effective for use.

What You Should Do

  1. The recalled products include several types of compounded injectable medications sold under the Olympia Pharmacy or Olympia Pharmaceuticals brands, including Formula F9, Sermorelin Acetate, NAD+, T-105, SB-4, Hydroxocobalamin B12, and Sincalide.
  2. Check your medication for lot numbers D41C19, D44026, F42104, D24005, C41008, E41F10, E41G10, E41C18, E41D18, E47025, or D24001. See the Affected Products section below for the full list of affected codes and expiration dates.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Formula F9 (Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL)
Variants: 10 mL multi-dose vial
Lot Numbers:
D41C19 (Exp. 4/19/22)
NDC:
73198-0004-10

Recall reason: Sub Potent

Product: Sermorelin Acetate Lyophilized powder for reconstitution
Variants: 9 mg per multi-dose vial
Lot Numbers:
D44026 (Exp. 4/26/22)
F42104 (Exp. 6/4/22)
NDC:
73198-0059-00

Recall reason: Sub Potent

Product: NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution
Variants: 500 mg per multi-dose vial
Lot Numbers:
D24005 (Exp. 4/5/22)
C41008 (Exp. 3/8/22)
NDC:
73198-0083-00

Recall reason: Product found to be Sub Potent or Exceeded reconstitution time

Product: T-105 (Papaverine 30 mg/mL, Phentolamine 1 mg/mL, PGE 10 mcg/mL)
Variants: 5 mL Multi-dose vial, 10 mL Multi-dose vial
Lot Numbers:
E41F10 (Exp. 5/10/22)
E41G10 (Exp. 5/10/22)
NDC:
73198-0005-05
73198-0005-10

Recall reason: Super Potent

Product: SB-4 (Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL)
Variants: 5 mL Multi-dose vial, 10 mL Multi-dose vial
Lot Numbers:
E41C18 (Exp. 5/18/22)
E41D18 (Exp. 5/18/22)
NDC:
73198-0023-05
73198-0023-10

Recall reason: Sub Potent

Product: Hydroxocobalamin B12 1mg/mL
Variants: 30 mL multi-dose vial
Lot Numbers:
E47025 (Exp. 5/21/22)
NDC:
73198-0080-30

Recall reason: Sub Potent

Product: Sincalide Lyophilized powder for reconstitution
Variants: 5 mcg per multi-dose vial
Lot Numbers:
D24001 (Exp. 4/1/22)
NDC:
73198-0082-00

Recall reason: Super Potent and Failed Reconstitution Time

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89717
Status: Resolved
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Sold By: Olympia Pharmaceuticals; Olympia Compounding Pharmacy
Manufactured In: United States
Units Affected: 7 products (2283 vials; 2634 vials; 493 vials.; 1093 vials; 1032 vials; 1613 vials; 836 vials)
Distributed To: Nationwide
Agency Last Updated: March 29, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.