Oxycodone HCl Tablets Recalled Due to Blister Cavity Containing Two Units
The Harvard Drug Group is recalling 12,717 Oxycodone HCl 5 mg tablets because a blister cavity was found containing two tablets instead of one.
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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of significant injury from a dosing error involving a potent opioid.
Plain-English summary
The Harvard Drug Group, LLC is recalling 12,717 Oxycodone HCl C-II Tablets, 5 mg USP, 100-count blister cards. The recall was initiated after a confirmed customer complaint identified a single unit dose blister cavity containing two tablets. The affected product is distributed nationwide and includes Lot # P-20000 and Lot # P-20004, both with an expiration date of 08/16.
The FDA has classified this as a Class II recall. The hazard involves a potential dosing error where a patient might inadvertently ingest two tablets instead of one. The product was manufactured by Nesher Pharmaceuticals USA LLC and distributed by Major Pharmaceuticals.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.
- Manufacturer
- The Harvard Drug Group, LLC
- Category
- Drug — Opioid Analgesic
- Affected units
- 12,717
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 # P-20000
- Exp. 08/16 Lot # P-20004
- Exp. 08/16
Distribution
Distributed nationwide across the United States.
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