Homeopathic drug Bacillinum Pulmo recalled for manufacturing deviations
Washington Homeopathic Products recalled Bacillinum Pulmo homeopathic drug due to manufacturing practice deviations. The Class II recall, initiated in May 2022 and terminated in May 2023, affected nationwide distribution.
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: This FDA Class II drug recall involves manufacturing practice violations (cGMP deviations) representing a risk-of-harm situation. No illnesses or injuries were reported in the source text. Per the severity rubric, drug recalls with potential health hazards but no reported illness are classified as High (score 3).
Plain-English summary
Washington Homeopathic Products, Inc. recalled Bacillinum Pulmo, a homeopathic drug available in potencies of 30C and 200C in liquid pellet form, distributed nationwide in the United States. The affected product was packaged in 5 glass amber bottles with Lot numbers 20308 and 20331.
The recall was initiated on May 13, 2022, due to current Good Manufacturing Practice (cGMP) deviations. These deviations indicate violations of FDA regulations governing drug manufacturing, processing, packaging, and storage required to ensure product quality and safety.
The recall was classified as FDA Class II and was voluntary, initiated by the firm. The recall was terminated on May 25, 2023.
Consumers who possess this product should discontinue use and consult their healthcare provider regarding whether alternative treatment is needed.
The recalled product
- Product
- Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
- Manufacturer
- Washington Homeopathic Products, Inc.
- Category
- Drug — Homeopathic
- Hazard
- manufacturing-defect
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 # 20308
- 20331
Distribution
Distributed nationwide across the United States.
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