Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16
Reported: November 20, 2019 Initiated: November 1, 2019 #D-0532-2020
Product Description
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16
Reason for Recall
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Details
- Recalling Firm
- KVK-Tech, Inc.
- Units Affected
- 1534 bottles
- Distribution
- Nationwide within the United States
- Location
- Newtown, PA
Frequently Asked Questions
What product was recalled? ▼
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16. Recalled by KVK-Tech, Inc.. Units affected: 1534 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0532-2020.
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