The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-363-2013·Announced 2013-05-22

Green Valley Drugs Recalls ED Mix Injections Due to Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 10,684 vials of ED Mix Injections nationwide due to a lack of assurance of sterility in compounded products.

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, an FDA Class II recall involving a significant safety hazard like lack of sterility assurance in injectable drugs is classified as Severe (Score 4), as it carries a risk of serious injury or death, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 10,684 vials of ED Mix Injections, including various strengths and presentations such as ED mix TM-at 2, ED-Mix BI-Mix 10 30 mL, and ED-Mix PGE 80-30. The products are prescription-only and were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility in 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 action.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k)…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Compounded Injectable
Hazard
Affected units
10,684

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 (20)

  • Lot #: a) ED mix TM -at 2: 20130306-M
  • Exp 6/6/2013
  • b) ED-Mix BI-Mix 10 30 mL: 130207120AE
  • Exp 5/7/2013
  • c) ED-Mix BI-Mix 9 30 mL: 20130121-G
  • Exp 4/21/2013
  • 20130301-F
  • Exp 5/1/2013
  • d) ED-Mix BI-Mix-3-30: 20130124-H
  • Exp 4/24/2013
  • 20130305-J
  • Exp 6/5/2013
  • e) ED-Mix PGE 80-30: 1302041000AE
  • Exp 5/4/2013
  • 20130313-B
  • Exp 6/13/2013
  • 20130322-H
  • Exp 6/22/2013
  • 20130405-I
  • Exp 7/5/2013

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 →

Related recalls

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

See all →

Same hazard · sterility

See all →

Similar recalls