Methocarbamol USP Recalled for Quality Assurance Deviations
American Pharmaceutical Ingredients LLC is recalling Methocarbamol USP due to lack of quality assurance at the API manufacturer.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Methocarbamol, USP, which is packaged in 100 g, 500 g, and 1,000 g containers. The product is intended for prescription compounding only and was packed under cGMP conditions. The affected lots are MCMR1308029NS and MCMR1308029NS-4202015, with an expiration date of 08/18.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations, specifically a lack of quality assurance at the API manufacturer. The agency has classified this recall as Class II.
The product was distributed nationwide. Consumers and healthcare providers should discontinue use of the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland…
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
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)
- Lots: MCMR1308029NS
- MCMR1308029NS-4202015
- Exp. 08/18
Distribution
Distributed nationwide across the United States.
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