The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0136-2019·Announced 2018-11-07

Pharm D Solutions Recalls Acetylcysteine Injection Due to Sterility Concerns

Pharm D Solutions is recalling Acetylcysteine Injection 10 mg/5 mL because the agency could not ensure the product was sterile.

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 classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the snippet, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of adverse health consequences, aligning with the Severe classification for Class II drug recalls where sterility is compromised.

Plain-English summary

Pharm D Solutions, LLC is recalling Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), NDC 69699-1424-10, due to a lack of assurance of sterility. The recall involves 486 milliliters of the product distributed nationwide.

The affected lots are 07032018:93, 07032018:27, and 07032018:97, all with a discard-by date of 01/03/2019. 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.

Healthcare providers and patients should stop using the affected lots and contact Pharm D Solutions for further instructions or a return.

The recalled product

Product
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
486

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 (3)

  • Lots: 07032018:93 Discard by: 01/03/2019
  • 07032018:27 Discard by: 01/03/2019
  • 07032018:97 Discard by: 01/03/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC 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 79 products in this recall →

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