Class II · Moderate risk
Atropine Sulfate injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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
Affected NDC
10702-0150-16
Compare with the code on your package — it is the most precise check available.
Drug: Atropine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydrocodone Bitartrate and Homatropine Methylbromide hydrocodone bitartrate and homatropine methylbromide oral solution NDC 10702-0150 |
HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mL | Liquid Oral |
KVK-Tech, Inc. | Rx · CII |
- Recalling firm
- KVK-Tech, Inc.
- NDC code
- 10702-150-16
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0532-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Atropine recalls
See all
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class I · High risk
Atropine Sulfate Injection
Presence of Particulate Matter; identified as glass
Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by KVK-Tech, Inc.
All 2019 recalls
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
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