Tri-Coast Pharmacy Recalls GAC Sterile Compounded Products Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 114 vials of GAC sterile compounded products nationwide due to a 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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility failures in injectable products) are categorized as Severe.
Plain-English summary
Tri-Coast Pharmacy is recalling 114 vials of GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL) sterile compounded products. The recall is being conducted because of a lack of assurance of sterility for these products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The distribution of these products was nationwide. Known lot codes included in the recall are 06172016A, 08092016B, 09262016A, and 10132016E.
Consumers and healthcare providers should check their inventory for these specific lot codes and discontinue use of the affected products. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy.
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 114
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)
- 08092016B (02/05/2014)
- 09262016A (03/25/2017)
- 10132016E (02/28/2017).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by Tri-Coast 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.
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