US Compounding Recalls HCG/B12 Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 7,852 vials of HCG/B12 injection nationwide because deficient practices may have impacted sterility assurance.
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. Per the rubric, FDA Class II recalls with potential for significant health consequences (such as sterility failure in injectable drugs) are classified as Severe (Score 4), as they are not Class I but involve risks beyond minor labeling or cosmetic issues.
Plain-English summary
US Compounding Inc is recalling 7,852 vials of HCG/B12 (5,000 units, 0.6 mg) 5 mL multi-dose vials. The product is intended for intramuscular or subcutaneous injection and is available by prescription only. The recall covers vials distributed nationwide with specific lot numbers and expiration dates listed in the recall notice.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry. This is an FDA Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for instructions on return or disposal. Patients should not self-administer the product until further guidance is provided.
The recalled product
- Product
- HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99
- Manufacturer
- US Compounding Inc
- Affected units
- 7,852
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 (15)
- Lot Numbers: 20150806@22 BUD: 12/5/2015
- 20150106@12 BUD: 11/28/2015
- 20150106@20 BUD: 11/28/2015
- 20150604@2 BUD: 10/3/2015
- 20150607@9 BUD: 1/2/2016
- 20150806@22 BUD: 12/5/2015
- 20151304@13 BUD: 10/10/2015
- 20151506@22 BUD: 12/12/2015
- 20152007@4 BUD: 1/16/2016
- 20152206@20 BUD: 12/19/2015
- 20152303@11 BUD: 9/19/2015
- 20152303@2 BUD: 9/19/2015
- 20152704@2 BUD: 10/24/2015
- 20152707@3 BUD: 1/23/2016
- 20152707@9 BUD: 1/23/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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