The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-764-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Oxytocin Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Oxytocin 20 units/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which aligns with the rubric criteria for Severe severity involving significant risk factors.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Oxytocin 20 units/ml Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

The affected product consists of three units of Oxytocin 20 units/ml Injection. The specific lot codes and expiration dates are B5019 (Exp 10/31/13), B3525 (Exp 8/25/13), and B3122 (Exp 8/22/13). The product was distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be stopped from use and returned to the pharmacy or supplier in accordance with the recall instructions.

The recalled product

Product
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injectable
Hazard
Affected units
3

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 (2)

  • B5019 Exp 10/31/13
  • B3525 Exp 8/25/13 and B3122 Exp 8/22/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 105 products in this recall →

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