The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0092-2016·Announced 2015-11-04

FDA Recalls Compounded Injectable Glutathione Due to Sterility Concerns

FDA is recalling compounded injectable glutathione from Moses Lake Professional Pharmacy due to a 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death from infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific lots of GLUTATHIONE MDV, Injectable Solution, 200 mg/mL. The product is compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, in Moses Lake, Washington. The recall involves syringes of 60 mL, 90 mL, 100 mL, and 150 mL sizes.

The recall was initiated because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The agency has classified this as a Class II recall. The affected product is prescription-only and was distributed nationwide.

Patients who have received this medication should consult their healthcare provider for guidance on next steps. The FDA advises consumers to check with their pharmacist or doctor regarding the specific lots involved in this recall.

The recalled product

Product
GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Manufacturer
JD & SN Inc., dba Moses Lake Professional Pharmacy
Category
Drug — Compounded Injectable
Hazard

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 (11)

  • t12012014@6
  • t09182014@28
  • t09162014@31
  • t09162014@22
  • t08292014@6
  • t08122014@26
  • t07222014@15
  • t05262015@13
  • t01192015@11
  • t05082015@4
  • t04202015@13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional 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 101 products in this recall →

Related recalls

Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls