The Recall Desk
HighFDA (Drugs)·D-0796-2022·Announced 2022-05-04

Diluent for Reconstitution Recalled Due to Manufacturing Compliance Failures

Olympia Pharmacy has recalled 45,935 vials of pharmaceutical diluent due to manufacturing compliance deviations. Environmental and personnel monitoring limits were exceeded and not properly investigated prior to October 2021.

What this means for you

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 classified this as a Class II recall, indicating potential for adverse health consequences. However, no illnesses or injuries have been reported, and no contamination has been confirmed. The recall is based on a manufacturing process compliance deviation rather than confirmed safety harm. This is classified as High severity based on the Class II designation and the pharmaceutical nature of the product, but limited to High rather than Severe due to lack of reported harm.

Plain-English summary

Olympia Compounding Pharmacy is recalling 45,935 vials of Diluent for Reconstitution, a pharmaceutical preparation containing 1.5% benzyl alcohol and sterile water for injection. The product is supplied in 10 mL multi-dose vials.

The recall was initiated due to manufacturing compliance deviations. Prior to October 1, 2021, the pharmacy failed to properly investigate instances when environmental and personnel monitoring exceeded established limits. This represents a deviation from Current Good Manufacturing Practice (CGMP) requirements.

The affected vials were distributed nationwide and are identified by specific lot codes with break-up dates ranging from April through August 2022. Healthcare providers and patients should consult the specific lot codes when determining if they have received recalled product.

The recalled product

Product
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Pharmaceutical Diluent
Hazard
  • cgmp-violation
  • contamination-risk

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 (11)

  • Lots: D41012 BUD 4/12/2022
  • D41212 BUD: 4/12/2022
  • D47026 BUD: 4/26/2022
  • E41017 BUD: 5/17/2022
  • E41018 BUD: 5/18/2022
  • E47004 BUD: 5/4/2022
  • E47024 BUD: 5/24/2022
  • E47026 BUD: 5/26/2022
  • E48005 BUD: 5/5/2022
  • G47014 BUD: 7/14/2022
  • H48816 BUD: 8/16/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category