Highest risk U.S. Food and Drug Administration

Envoachem Pharmaceuticals Dyural-40 and Dyural-80 recall: Due to Latex Hazard

Recall published 7+ years ago

Due to Latex Hazard

Envoachem Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugsEnvoachem Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
December 17, 2018
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Envoachem Pharmaceuticals
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Dyural-40 and Dyural-80

What the company announced

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Asclemed USA Inc has not received any reports of adverse events related to this recall.

The products are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing Sodium Chloride, USP, 0.9% by Fresenius Kabi.

The affected Dyural-40 lots include the following:

  • LOT: 051518X5 · EXP: 1/31/2019 · LOT: 072518X3 · EXP: 5/31/2019 · LOT: 090518X4 · EXP: 6/30/2019 · LOT: 092418X1 · EXP: 8/31/2019
  • LOT: 051618X1 · EXP: 1/31/2019 · LOT: 072718X1 · EXP: 5/31/2019 · LOT: 091818X2 · EXP: 1/31/2019 · LOT: 092818X4 · EXP: 8/31/2019
  • LOT: 052318X4 · EXP: 5/1/2019 · LOT: 080318X2 · EXP: 5/31/2019 · LOT: 091818X3 · EXP: 7/31/2019 · LOT: 101018X3 · EXP: 8/31/2019
  • LOT: 052318X5 · EXP: 5/31/2019 · LOT: 082318X4 · EXP: 6/30/2019 · LOT: 091818X4 · EXP: 6/30/2019 · LOT: 101018X5 · EXP: 8/31/2019
  • LOT: 062818X1 · EXP: 5/31/2019 · LOT: 083118X1 · EXP: 6/30/2019 · LOT: 091818X5 · EXP: 8/31/2019 · LOT: 102418X5 · EXP: 9/30/2019

The affected Dyural-80 lots include the following:

  • LOT: 050918X1 · EXP: 12/31/2018 · LOT: 062718X1 · EXP: 6/30/2019 · LOT: 080718X7 · EXP: 6/30/2019 · LOT: 100518X6 · EXP: 7/31/2019
  • LOT: 051518X4 · EXP: 5/31/2019 · LOT: 062718X2 · EXP: 6/30/2019 · LOT: 080918X3 · EXP: 6/30/2019 · LOT: 101118X3 · EXP: 7/31/2019
  • LOT: 051618X10 · EXP: 12/31/2018 · LOT: 062818X3 · EXP: 6/30/2019 · LOT: 083018X2 · EXP: 6/30/2019 · LOT: 101518X2 · EXP: 7/31/2019
  • LOT: 051818X4 · EXP: 12/31/2018 · LOT: 062818X4 · EXP: 6/30/2019 · LOT: 083118X2 · EXP: 6/30/2019 · LOT: 101618X7 · EXP: 7/31/2019
  • LOT: 051818X5 · EXP: 5/31/2019 · LOT: 070918X1 · EXP: 6/30/2019 · LOT: 083118X5 · EXP: 6/30/2019 · LOT: 101618X8 · EXP: 7/31/2019
  • LOT: 052118X4 · EXP: 5/31/2019 · LOT: 071018X5 · EXP: 6/30/2019 · LOT: 090518X5 · EXP: 6/30/2019 · LOT: 101818X3 · EXP: 7/31/2019
  • LOT: 052118X5 · EXP: 5/31/2019 · LOT: 071118X4 · EXP: 6/30/2019 · LOT: 090518X6 · EXP: 7/31/2019 · LOT: 101918X1 · EXP: 7/31/2019
  • LOT: 052918X7 · EXP: 5/31/2019 · LOT: 071118X5 · EXP: 6/30/2019 · LOT: 090718X2 · EXP: 7/31/2019 · LOT: 102318X1 · EXP: 7/31/2019
  • LOT: 061118X8 · EXP: 5/1/2019 · LOT: 071718X2 · EXP: 2/28/2019 · LOT: 090718X3 · EXP: 7/31/2019 · LOT: 103118X1 · EXP: 7/31/2019
  • LOT: 061118X9 · EXP: 5/31/2019 · LOT: 072018X6 · EXP: 6/30/2019 · LOT: 090718X5 · EXP: 7/31/2019 · LOT: 103118X2 · EXP: 7/31/2019
  • LOT: 061118X10 · EXP: 5/31/2019 · LOT: 072418X3 · EXP: 6/30/2019 · LOT: 091118X7 · EXP: 7/31/2019 · LOT: 103118X3 · EXP: 9/30/2019
  • LOT: 061418X2 · EXP: 5/31/2019 · LOT: 072418X4 · EXP: 6/30/2019 · LOT: 091318X5 · EXP: 7/31/2019 · LOT: 110618X1 · EXP: 9/30/2019
  • LOT: 061518X1 · EXP: 5/31/2019 · LOT: 072518X2 · EXP: 6/30/2019 · LOT: 091918X1 · EXP: 7/31/2019 · LOT: 110818X1 · EXP: 9/30/2019
  • LOT: 061518X2 · EXP: 6/30/2019 · LOT: 073018X4 · EXP: 6/30/2019 · LOT: 092718X1 · EXP: 7/31/2019
  • LOT: 061918X2 · EXP: 6/30/2019 · LOT: 073018X8 · EXP: 6/30/2019 · LOT: 092718X2 · EXP: 7/31/2019
  • LOT: 062518X2 · EXP: 6/30/2019 · LOT: 080218X3 · EXP: 6/30/2019 · LOT: 092818X3 · EXP: 7/31/2019

The products can be identified by lot and expiration stamped on the front of each convenience kit. Product was distributed Nationwide to distributors and physicians.

Asclemed USA Inc is notifying its distributors and customers by email and is arranging for return of all recalled products. Distributors and physicians that have Dyural-40 or Dyural-80 which is being recalled should stop using them and return to place of purchase.

Consumers with questions regarding this recall can contact Asclemed USA Inc by calling (310) 320-0100 ext. 120 Monday through Friday from 7:30am to 4:00pm PST or emailing [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm1

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 30 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • Dyural-40
  • 61
  • Dyural-80
  • 051518X5
  • 072518X3
  • 090518X4
  • 092418X1
  • 051618X1
  • 072718X1
  • 091818X2
  • 092818X4
  • 052318X4
  • 080318X2
  • 091818X3
  • 101018X3
  • 052318X5
  • 082318X4
  • 091818X4
  • 101018X5
  • 062818X1

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 1/31/2019
  • 5/31/2019
  • 6/30/2019
  • 8/31/2019
  • 5/1/2019
  • 7/31/2019
  • 9/30/2019
  • 12/31/2018
  • 2/28/2019

Model or item number

On the rating label, the box or the instruction sheet.

  • 0.9

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Envoachem Pharmaceuticals — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Asclemed USA Inc dba Envoachem Pharmeceuticals — Consumers: Asclemed USA Inc, (310) 320-0100 ext. 120, [email protected] — Media: Christina Hopson, (310) 320-0100 ext. 120

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Envoachem Pharmaceuticals prescription & otc drugs recalled?

Due to Latex Hazard For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code Dyural-40, 61, Dyural-80; best-by date 1/31/2019 or 5/31/2019; model number 0.9. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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