Macleods Pharma Recalls Pioglitazone Tablets Due to Superpotent Content
Macleods Pharma USA is recalling 31,968 bottles of Pioglitazone Hydrochloride 15 mg tablets because the product is superpotent.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is 'superpotent' content, which poses a risk of harm but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause harm).
Plain-English summary
Macleods Pharma USA, Inc. is voluntarily recalling 31,968 bottles of Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles. The recall is initiated because the product is superpotent. The affected product is identified by Lot # BPF901A with an expiration date of 12/2021 and NDC 33342-054-07.
The product was manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India, and shipped to 8 distributors who may have further distributed the product. The recall was initiated on September 23, 2019, and was classified as Class II by the FDA on October 11, 2019.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance. The recall status is currently terminated as of February 23, 2021.
The recalled product
- Product
- PIOGLITAZONE (PIOGLITAZONE)
- Brand
- PIOGLITAZONE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 31,968
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)
- Lot # BPF901A
- exp. date 12/2021
UPCs (6)
- 0333342056153
- 0333342055101
- 0333342056078
- 0333342056108
- 0333342054104
- 0333342055071
Distribution
Distribution scope not specified by the agency.
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