Agency classClass IIOur severity:Severe FDA (Drugs)·D-1566-2015·Announced 2015-09-23

Mannitol 5% Injectable Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Mannitol 5% Injectable vials because FDA inspections found GMP violations that may impact 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 involves a sterile injectable product where GMP violations impact sterility assurance, posing a significant risk of infection or injury.

Plain-English summary

The Compounding Pharmacy of America is recalling Mannitol 5% Injectable, Multi-Dose Vials. The recall involves 425 ml total of the sterile, room-temperature product distributed nationwide between November 2014 and May 2015. Specific lots include 04072015@30 (expiration 7/6/2015) and 05042015@23 (expiration 8/2/2015).

The recall was initiated due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this recall as Class II.

Healthcare providers and patients should stop using the affected Mannitol 5% Injectable vials and contact the recalling firm for further instructions. Consumers should verify lot numbers against the recall notice to determine if their product is affected.

The recalled product

Product: Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility
gmp-violation

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 (5)

All lots distributed between November 2014 and May 2015
04072015@30
7/6/2015
05042015@23
8/2/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility