The Recall Desk
ModerateFDA (Drugs)·D-181-2013·Announced 2013-03-13

Bristol Myers Squibb Recalls Abilify Tablets Due to Manufacturing Error

Bristol Myers Squibb is recalling specific Abilify 30 mg tablets because rejected material was inadvertently shipped. The affected product was distributed in LA, TN, and CA.

What this means for you

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 is a reasonable probability of temporary or medically reversible adverse health consequences. The source text describes a manufacturing deviation (CGMP) where rejected material was shipped, but does not report any specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Bristol Myers Squibb Manufacturing Company is recalling 21 blister packs of Abilify (aripiprazole) 30 mg tablets. The recall involves NDC 59148-011-35, with lot code 2E69023A and an expiration date of February 28, 2015. The affected product was distributed in Louisiana, Tennessee, and California.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. During the manufacturing process, a drum of Abilify 30 mg tablets that was rejected at the compression stage was not properly segregated from the rest of the lot. Consequently, this rejected material was inadvertently shipped, packaged, and distributed to customers.

Patients and healthcare providers who have the specific lot identified in this recall should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot and distribution areas mentioned above.

The recalled product

Product
ABILIFY (ARIPIPRAZOLE)
Brand
ABILIFY
Affected units
21

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 (2)

  • 2E69023A
  • Exp. FEB 28 2015

Distribution

Distributed in 3 states: