The Recall Desk
SevereFDA (Drugs)·D-653-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Methionine/Choline/Inositol/B-12 Injection

Clinical Specialties Compounding Pharmacy is recalling Methionine/Choline/Inositol/B-12 products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterility concerns in injectable products which pose a risk of serious injury.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling specific lots of Methionine/Choline/Inositol/B-12 products. The recall involves 255ml total quantities of the product, specifically Lot number CABDAHAB:35 with an expiration date of 4/7/2013 and Lot number CABDBIAC:77 with an expiration date of 5/19/2013.

The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes, specifically a lack of assurance of sterility. The affected products were distributed in Florida, Georgia, and South Carolina.

Consumers and healthcare providers who have these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Affected units
255

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)

  • Lot number CABDAHAB:35
  • Exp date: 4/7/2013 and Lot number CABDBIAC:77
  • Exp date: 5/19/2013.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 49 recalled by Clinical Specialties 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 49 products in this recall →