RX3 Pharmacy Recalls Medi-bolic Booster Injectable Due to Manufacturing Deviations
RX3 Pharmacy is recalling 126 vials of Medi-bolic Booster Injectable because the product was not manufactured according to Good Manufacturing Procedures.
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 agency classified this recall as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural or manufacturing deviations in injectable pharmaceuticals.
Plain-English summary
RX South LLC DBA RX3 Pharmacy is recalling 126 vials of Medi-bolic Booster Injectable. The product consists of 30 mL multi-dose vials containing methionine, choline chloride, inositol, cyanocobalamin (Vitamin B12), and chromium chloride. The recall is limited to two specific lots: 10292012:56 (expiration date 01/27/13) and 10302012:77 (expiration date 01/28/13).
The recall was initiated because the pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures (CGMP Deviations). The agency has classified this recall as Class II. The affected products were distributed nationwide.
Consumers who possess these specific vials should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.
- Manufacturer
- RX South LLC DBA RX3 Pharmacy
- Category
- Drug — Injectable
- Affected units
- 126
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 #: 10292012:56
- Exp 01/27/13 and 10302012:77
- Exp 01/28/13
Distribution
Distributed nationwide across the United States.
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