The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-765-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling six vials of Papaverine 40 mg/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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be assigned a score of 4 (Severe) and cannot be scored lower.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling six vials of Papaverine 40 mg/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 compounded product.

The affected product was distributed nationwide and in Puerto Rico. Specific lot codes and expiration dates for the recalled units include B0021 (Exp 8/31/13), B0013 (Exp 8/1/13), C5122 (Exp 9/22/13), C51101 (Exp 8/1/13), C5508 (Exp 9/8/13), and C5119 (Exp 9/19/13).

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injection
Hazard
Affected units
6

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 (6)

  • B0021 Exp 8/31/13
  • B0013 Exp 8/1/13
  • C5122 Exp 9/22/13
  • C51101 Exp 8/1/13
  • C5508 Exp 9/8/13
  • and C5119 Exp 9/19/13

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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