The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0105-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

JD & SN Inc. is recalling specific syringes of Methylcobalamin Injectable Solution because the FDA cannot assure the sterility of the compounded drug.

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 involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if the product is contaminated.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling specific lots of Methylcobalamin MDV Injectable Solution. The recall covers syringes in various sizes, including 4 mL, 10 mL, 12 mL, 15 mL, 30 mL, 50 mL, and 60 mL. The product is a prescription-only compounded drug.

The recall was initiated due to a lack of assurance of sterility. The FDA has determined that it cannot guarantee that all sterile human compounded drugs within their expiration dates are sterile. This classification is designated as Class II by the agency.

The affected products were distributed nationwide. Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 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 — Injectable Solution
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 (20)

  • t12232014@10
  • t12052014@10
  • t11182014@16
  • t11182014@1
  • t10202014@5
  • t10132014@2
  • t09292014@7
  • t07082015@6
  • t07082015@30
  • t06112015@31
  • t06092015@34
  • t06052015@27
  • t06022015@9
  • t05282015@22
  • t05262015@8
  • t05202015@31
  • t04272015@11
  • t04132015@19
  • t03182015@46
  • t03172015@15

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 →

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