The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0178-2019·Announced 2018-11-07

Pharm D Solutions Recalls Reck Injection Due to Sterility Concerns

Pharm D Solutions is recalling 517 syringes of Reck Injection because the product lacks assurance of sterility. The recall covers lots distributed nationwide.

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 3/5 (High).

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: The recall involves a risk-of-harm product (injection) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Pharm D Solutions, LLC is recalling 517 syringes of Reck Injection (NDC 69699-1459-50). The recall was initiated because the product lacks assurance of sterility. The affected lots were distributed nationwide.

The recall includes specific lot numbers with discard dates ranging from April 25, 2018, to September 28, 2018. The source text does not report any illnesses or injuries associated with the use of these products.

Consumers and healthcare providers should stop using the affected Reck Injection syringes and contact Pharm D Solutions, LLC for further instructions or a return.

The recalled product

Product
Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injection
Hazard
Affected units
517

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 (12)

  • Lot: 03262018:11 Discard by: 4/25/2018
  • 04102018:38 Discard by: 5/10/2018
  • 05312018:63 Discard by: 6/30/2018
  • 05032018:97 Discard by: 6/2/2018
  • 06082018:24 Discard by: 7/8/2018
  • 05212018:80 Discard by: 6/20/2018
  • 07102018:60 Discard by: 8/9/2018
  • 06202018:44 Discard by: 7/19/2018
  • 07232018:08 Discard by: 8/22/2018
  • 07022018:62 Discard by: 8/1/2018
  • 08292018:95 Discard by: 9/28/2018
  • 08202018:61 Discard by: 9/19/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC 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 79 products in this recall →

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