The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1007-2020·Announced 2020-03-18

Redline Pharmacy Recalls Morphine Sulfate Due to Processing Control Deficiencies

Redline Pharmacy Solutions is recalling Morphine Sulfate 20 mg/mL intrathecal syringes due to a lack of processing controls. The product was sold to patients in Nebraska.

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. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Redline Pharmacy Solutions is recalling Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. The recall was initiated because of a lack of processing controls during the manufacturing or preparation of the product.

The affected product is identified by Lot 02242020@2. According to the source text, the product was sold to patients in Nebraska. 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.

Patients who have received this specific lot of Morphine Sulfate should contact their healthcare provider or pharmacist for further instructions on how to proceed. No specific instructions for disposal or return are provided in the source text.

The recalled product

Product
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Manufacturer
Redline Pharmacy Solutions
Category
Drug — 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 (1)

  • Lot 02242020@2

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 6 recalled by Redline Pharmacy Solutions 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 6 products in this recall →

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