The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1123-2015·Announced 2015-06-17

Montana Compounding Pharmacy Recalls Hyaluronidase Injectable Solution Due to Sterility Concerns

Montana Compounding Pharmacy is recalling Hyaluronidase Injectable Solution because FDA inspectors observed objectionable conditions that raised concerns about the product's 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 rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are Severe. While the source does not explicitly report injuries, the 'Lack of Assurance of Sterility' for an injectable product is a significant safety hazard that aligns with the Severe classification for Class II recalls involving potential serious harm.

Plain-English summary

Montana Compounding Pharmacy in Missoula, MT, is recalling Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vials. The recall was initiated because FDA inspectors observed objectionable conditions during an inspection that raised a lack of assurance of sterility for the product.

The affected product is a prescription-only compounded injectable solution. The recall covers specific lots with expiry dates ranging from May 17, 2015, to June 30, 2015. The product was distributed in Montana and North Dakota.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies 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
Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Manufacturer
Montana Compounding 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 (7)

  • Lot 02062015:06@3
  • expiry date: 5/17/2015
  • Lot 02272015:93@1
  • expiry date: 6/30/2015
  • Lot 03252015:92@7
  • Lot 04162015:63@7
  • expiry date: 6/30/2015.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 12 recalled by Montana Compounding 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 12 products in this recall →

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