FDA Recalls Propranolol HCL Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets because they may have been mislabeled as other drugs. The repacked drugs were distributed in four western states.
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 recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the risk of administering the wrong medication (Lorazepam vs. Propranolol) which can lead to significant adverse health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Propranolol HCL, Tablet, 10 mg (NDC 00603-548-221) due to a potential label mixup. The recalled product consists of 200-tablet packages of repacked prescription medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recall was initiated because the Propranolol HCL tablets may have been mislabeled as Lorazepam, Tablet, 0.25 mg (NDC 00591-024-001) or as a different lot of Propranolol HCL, Tablet, 10 mg (NDC 23155-011-001). The specific pedigree codes for the affected Propranolol HCL are AD60264_1 (expiration 5/22/2014) and W003032 (expiration 6/12/2014). The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should check their medication for the NDC 00603-548-221 and the pedigree codes listed above. If the medication matches these details, it should be returned to the pharmacy or distributor for replacement or refund. Patients should not discontinue their medication without consulting their healthcare provider.
The recalled product
- Product
- PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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 (6)
- PROPRANOLOL HCL
- Tablet
- 10 mg has the following codes: Pedigree: AD60264_1
- EXP: 5/22/2014
- Pedigree: W003032
- EXP: 6/12/2014.
Distribution
Part of a larger recall action
This product is one of 265 recalled by Aidapak Services, LLC 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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