Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.
Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.
Empty capsules could result in missed dose(s) of gabapentin, resulting in adverse health consequences that could range from no effect, short-term reduction in efficacy, short-term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. Aurobindo Pharma USA has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules, the company said in a press release.
Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on the yellow cap and 03 on the yellow body with black edible ink. The product was distributed through the Northstar label to retail outlets nationwide.
Aurobindo Pharma USAis notifying its distributors and customers by recall letters and is arranging for return of all recalled product. Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return it to place of purchase.
Source: FDA
Market Demands and Emerging Technologies Shape Outsourcing Models
June 5th 2025Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.