Hyaluronidase Recalled Due to Lack of Assurance of Sterility
Specialty Medicine Compounding Pharmacy is recalling Hyaluronidase products because sterility cannot be assured after a related product was found non-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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a risk of serious health consequences (lack of sterility) maps to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High due to the potential for serious injury from non-sterile medical products.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Hyaluronidase, pf 100U/mL and pf 150 U/mL. The recall was initiated because the products were compounded in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled Hyaluronidase products cannot be assured.
The affected products are prescription-only sterile compounded human and veterinary products. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers include 09232013@3, 09102013@5, t09172013@20, 09252013@4, 09252013@7, 10022013@12, 10082013@6, 10142013@58, and 10152013@1.
The products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- 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 (11)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s:09232013@3
- 09102013@5
- t09172013@20
- 09252013@4
- 09252013@7
- 10022013@12
- 10082013@6
- 10142013@58
- 10152013@1
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Specialty Medicine 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.
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