The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0104-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Methylcobalamin Injectable Solution because the agency 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 FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a drug with a sterility assurance issue is categorized as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Methylcobalamin Injectable Solution, 15 MG/ML, in various syringe sizes (5 mL, 6 mL, 10 mL, 15 mL, 20 mL, and 30 mL). The recall is being conducted because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the sterile human compounded drugs within their expiration dates.

The affected product is prescription-only (Rx only) and was distributed nationwide. The recall covers specific lots identified by codes ranging from t01052015 to 03312015. The total quantity involved includes 1 syringe of 5 mL, 1 syringe of 6 mL, 18 syringes of 10 mL, 1 syringe of 15 mL, 3 syringes of 20 mL, and 3 syringes of 30 mL.

Consumers and healthcare providers should stop using the recalled Methylcobalamin Injectable Solution and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 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)

  • t12312014@6
  • t12042014@26
  • t11252014@31
  • t10302014@35
  • t10282014@27
  • t10242014@14
  • t10032014@26
  • t10012014@18
  • t09302014@13
  • t09222014@22
  • t09172014@24
  • t09052014@1
  • t08132014@16
  • t07302014@2
  • t07222014@21
  • t06302015@5
  • t06182015@4
  • t04102015@10
  • t04062015@2
  • t03062015@8

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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