The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-375-2013·Announced 2013-05-22

Green Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection nationwide due to lack of assurance of sterility.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks such as sterility failures in injectable drugs are categorized as Severe.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection, all strengths and presentations, including 250 mg/mL in 1 mL, 4 mL, 5 mL, and 10 mL vials. The product was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes as the reason for the recall.

Affected lots include Hydroxyprogesterone Caproate 250 mg/mL 4 mL with lot numbers 20130204-A (Exp 5/4/2013) and 20130117-G (Exp 4/17/2013). Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
229

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 (5)

  • Lot #: Hydroxyprogesterone Caproate 250 mg/mL 4 mL: 20130204-A
  • Exp 5/4/2013
  • 20130117-G
  • Exp 4/17/2013
  • 20130204-A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs 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 78 products in this recall →

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